Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial "CABANA"

Active, not recruiting

Phase N/A Results N/A

Update History

4 Aug '17
The description was updated.
New
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
Old
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: - Over the preceding 6 months have: 1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or 2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or 3. electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year). - Warrant active therapy (within the past 3 months) beyond simple ongoing observation - Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs. - Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or EF ≤35. - Have the capacity to understand and sign an informed consent form. - Be ≥18 years of age. - NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment. Exclusion Criteria: - Lone AF in the absence of risk factors for stroke in patients <65 years of age - Patients who in the opinion of the managing clinician should not yet receive any therapy for AF - Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2) - An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time - Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma - Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months - Hypertrophic obstructive cardiomyopathy (outflow track) - Class IV angina or Class IV CHF (including past or planned heart transplantation) - Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF) - Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs - Prior LA catheter ablation with the intention of treating AF - Prior surgical interventions for AF such as the MAZE procedure - Prior AV nodal ablation - Patients with other arrhythmias requiring ablative therapy - Contraindication to appropriate anti-coagulation therapy - Renal failure requiring dialysis - Medical conditions limiting expected survival to <1 year - Women of childbearing potential (unless post-menopausal or surgically sterile) - Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center) - Unable to give informed consent - NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.
Old
Inclusion Criteria: - Over the preceding 6 months have: 1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or 2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or 3. electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year). - Warrant active therapy (within the past 3 months) beyond simple ongoing observation - Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs. - Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or EF ≤35. - Have the capacity to understand and sign an informed consent form. - Be ≥18 years of age. - NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment. Exclusion Criteria: - Lone AF in the absence of risk factors for stroke in patients <65 years of age - Patients who in the opinion of the managing clinician should not yet receive any therapy for AF - Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2) - An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time - Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma - Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months - Hypertrophic obstructive cardiomyopathy (outflow track) - Class IV angina or Class IV CHF (including past or planned heart transplantation) - Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF) - Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs - Prior LA catheter ablation with the intention of treating AF - Prior surgical interventions for AF such as the MAZE procedure - Prior AV nodal ablation - Patients with other arrhythmias requiring ablative therapy - Contraindication to appropriate anti-coagulation therapy - Renal failure requiring dialysis - Medical conditions limiting expected survival to <1 year - Women of childbearing potential (unless post-menopausal or surgically sterile) - Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center) - Unable to give informed consent - NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.
28 Apr '16
A location was updated in Little Rock.
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17 Sep '15
A location was updated in Sacramento.
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A location was updated in Nashville.
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The overall status was removed for Vanderbilt University Medical Center.
22 Jan '15
A location was updated in Houston.
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The overall status was removed for University of Texas Health Science Center.
24 Jan '14
The Summary of Purpose was updated.
New
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.
Old
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated AF.
The description was updated.
New
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
Old
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize 3000 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥3 rate control drugs. Pts will be followed every 6 months for >2 yrs and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
The eligibility criteria were updated.
New
Inclusion Criteria: - Over the preceding 6 months have: 1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or 2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or 3. electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year). - Warrant active therapy (within the past 3 months) beyond simple ongoing observation - Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs. - Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or EF ≤35. - Have the capacity to understand and sign an informed consent form. - Be ≥18 years of age. - NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment. Exclusion Criteria: - Lone AF in the absence of risk factors for stroke in patients <65 years of age - Patients who in the opinion of the managing clinician should not yet receive any therapy for AF - Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2) - An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time - Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma - Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months - Hypertrophic obstructive cardiomyopathy (outflow track) - Class IV angina or Class IV CHF (including past or planned heart transplantation) - Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF) - Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs - Prior LA catheter ablation with the intention of treating AF - Prior surgical interventions for AF such as the MAZE procedure - Prior AV nodal ablation - Patients with other arrhythmias requiring ablative therapy - Contraindication to appropriate anti-coagulation therapy - Renal failure requiring dialysis - Medical conditions limiting expected survival to <1 year - Women of childbearing potential (unless post-menopausal or surgically sterile) - Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center) - Unable to give informed consent - NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.
Old
Inclusion Criteria: - Have the capacity to understand and sign an informed consent form - Be ≥18 years of age. - Have documented AF episodes ≥1 hour in duration; with ≥2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week - Warrant active therapy beyond simple ongoing observation - Be eligible for both catheter ablation and ≥2 sequential rhythm control and/or ≥3 rate control drugs. - Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure, Prior stroke or TIA, LA size ≥5.0 cm (or volume index ≥40 cc/m2), or EF ≥35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify. Exclusion Criteria: - Lone AF in the absence of risk factors for stroke in patients <65 years of age - Patients who in the opinion of the managing clinician should not yet receive any therapy for AF - Patients who have failed ≥2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy - More than one week of amiodarone treatment in the past 3 months - An efficacy failure of full dose amiodarone treatment ≥12 weeks duration at any time - Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma - Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months - Hypertrophic obstructive cardiomyopathy - Class IV angina or Class IV CHF (including past or planned heart transplantation) - Other mandated anti-arrhythmic drug therapy - Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs - Prior LA catheter ablation with the intention of treating AF - Prior surgical interventions for AF such as the MAZE procedure - Prior AV nodal ablation - Patients with other arrhythmias requiring ablative therapy - Contraindication to warfarin anti-coagulation - Renal failure requiring dialysis - Medical conditions limiting expected survival to <1 year - Women of childbearing potential (unless post-menopausal or surgically sterile) - Participation in any other clinical mortality trial - Unable to give informed consent
A location was updated in Washington.
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The overall status was updated to "Recruiting" at Washington Hospital Center.
A location was updated in St. Petersburg.
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The overall status was removed for Northside Hospital and Heart Institute.
A location was updated in West Des Moines.
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The overall status was removed for Mercy Medical Center-Iowa Heart Center.
A location was updated in Boston.
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The overall status was updated to "Recruiting" at Boston Medical Center.
A location was updated in Houston.
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The overall status was removed for University of Texas Health Science Center.
A location was updated in Huntington.
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The overall status was updated to "Recruiting" at Saint Marys Hospital.
A location was updated in Cotignola.
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The overall status was updated to "Active, not recruiting" at Maria Cecilia Hospital.
A location was updated in Moscow.
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The overall status was removed for Clinical Hospital # 83 under the Federal Medical and Biological Agency.
8 Mar '13
A location was updated in St. Petersburg.
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The overall status was removed for Northside Hospital and Heart Institute.
A location was updated in St. Petersburg.
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The overall status was removed for Northside Hospital and Heart Institute.
1 Mar '13
A location was updated in Kissimmee.
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The overall status was updated to "Recruiting" at Osceola Regional Medical Center.
A location was updated in St. Petersburg.
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The overall status was removed for Northside Hospital and Heart Institute.
A location was updated in London.
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The overall status was updated to "Recruiting" at The Heart Hospital.
15 Jun '12
Trial name was updated.
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Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
The Summary of Purpose was updated.
New
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated AF.
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The CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated AF.
A location was updated in Chattanooga.
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The overall status was removed for Memorial Health Care System.
A location was updated in Westmead.
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The overall status was updated to "Recruiting" at Westmead Hospital.
21 Apr '12
A location was updated in Cincinnati.
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The overall status was removed for University of Cincinnati Medical Center.
31 Mar '12
A location was updated in Coburg.
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The overall status was updated to "Recruiting" at Klinikum Coburg.
22 Nov '11
A location was updated in Milan.
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The overall status was updated to "Recruiting" at Policlinico San Donato.
2 Nov '11
A location was updated in Danville.
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The overall status was removed for Geisinger Wyoming Valley Medical Center.
A location was updated in Tomsk.
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The overall status was removed for Scientific Research Institute of Cardiology of Ministry of Health of Russian Foundation.
14 Oct '11
A location was updated in London.
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The overall status was updated to "Recruiting" at St. Mary's Hospital Imperial College Healthcare NHS Trust.
6 Oct '11
The description was updated.
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The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize 3000 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥3 rate control drugs. Pts will be followed every 6 months for >2 yrs and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
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The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize 3000 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (?65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ?2 anti-arrhythmic or ?3 rate control drugs. Pts will be followed every 6 months for >2 yrs and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
4 Oct '11
The description was updated.
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The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize 3000 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥3 rate control drugs. Pts will be followed every 6 months for >2 yrs and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
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The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize 3000 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (?65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ?2 anti-arrhythmic or ?3 rate control drugs. Pts will be followed every 6 months for >2 yrs and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
The eligibility criteria were updated.
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Inclusion Criteria: - Have the capacity to understand and sign an informed consent form - Be ≥18 years of age. - Have documented AF episodes ≥1 hour in duration; with ≥2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week - Warrant active therapy beyond simple ongoing observation - Be eligible for both catheter ablation and ≥2 sequential rhythm control and/or ≥3 rate control drugs. - Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure, Prior stroke or TIA, LA size ≥5.0 cm (or volume index ≥40 cc/m2), or EF ≥35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify. Exclusion Criteria: - Lone AF in the absence of risk factors for stroke in patients <65 years of age - Patients who in the opinion of the managing clinician should not yet receive any therapy for AF - Patients who have failed ≥2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy - More than one week of amiodarone treatment in the past 3 months - An efficacy failure of full dose amiodarone treatment ≥12 weeks duration at any time - Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma - Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months - Hypertrophic obstructive cardiomyopathy - Class IV angina or Class IV CHF (including past or planned heart transplantation) - Other mandated anti-arrhythmic drug therapy - Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs - Prior LA catheter ablation with the intention of treating AF - Prior surgical interventions for AF such as the MAZE procedure - Prior AV nodal ablation - Patients with other arrhythmias requiring ablative therapy - Contraindication to warfarin anti-coagulation - Renal failure requiring dialysis - Medical conditions limiting expected survival to <1 year - Women of childbearing potential (unless post-menopausal or surgically sterile) - Participation in any other clinical mortality trial - Unable to give informed consent
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Inclusion Criteria: - Have the capacity to understand and sign an informed consent form - Be ?18 years of age. - Have documented AF episodes ?1 hour in duration; with ?2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week - Warrant active therapy beyond simple ongoing observation - Be eligible for both catheter ablation and ?2 sequential rhythm control and/or ?3 rate control drugs. - Be ?65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure, Prior stroke or TIA, LA size ?5.0 cm (or volume index ?40 cc/m2), or EF ?35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify. Exclusion Criteria: - Lone AF in the absence of risk factors for stroke in patients <65 years of age - Patients who in the opinion of the managing clinician should not yet receive any therapy for AF - Patients who have failed ?2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy - More than one week of amiodarone treatment in the past 3 months - An efficacy failure of full dose amiodarone treatment ?12 weeks duration at any time - Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma - Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months - Hypertrophic obstructive cardiomyopathy - Class IV angina or Class IV CHF (including past or planned heart transplantation) - Other mandated anti-arrhythmic drug therapy - Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs - Prior LA catheter ablation with the intention of treating AF - Prior surgical interventions for AF such as the MAZE procedure - Prior AV nodal ablation - Patients with other arrhythmias requiring ablative therapy - Contraindication to warfarin anti-coagulation - Renal failure requiring dialysis - Medical conditions limiting expected survival to <1 year - Women of childbearing potential (unless post-menopausal or surgically sterile) - Participation in any other clinical mortality trial - Unable to give informed consent
A location was updated in Stony Brook.
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The overall status was removed for Stony Brook University Hospital and Medical Center.
A location was updated in Vancouver.
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The overall status was updated to "Recruiting" at Saint Pauls Hospital.