Optimal Anticoagulation for Higher Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial "OCEAN"

Recruiting

Phase 4 Results N/A

Update History

26 Apr '17
The gender criteria for eligibility was updated to "All."
A location was updated in Calgary.
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The overall status was updated to "Recruiting" at Foothills Medical Centre.
A location was updated in New West Minster.
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The overall status was updated to "Recruiting" at Royal Columbian/Fraser Clinical Trials.
A location was updated in Vancouver.
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The overall status was updated to "Recruiting" at St. Paul's Hospital.
A location was updated in Victoria.
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The overall status was updated to "Recruiting" at Victoria Cardiac Arrhythmia Trials Inc..
A location was updated in Hamilton.
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The overall status was updated to "Recruiting" at Hamilton Health Sciences Centre.
A location was updated in London.
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The overall status was updated to "Recruiting" at London Health Sciences Centre.
A location was updated in Ottawa.
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The overall status was updated to "Recruiting" at University of Ottawa Heart Institute.
A location was updated in Toronto.
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The overall status was updated to "Recruiting" at St. Michael's Hospital.
A location was updated in Montreal.
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The overall status was updated to "Recruiting" at McGill University Health Centre.
A location was updated in Quebec City.
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The overall status was updated to "Recruiting" at Institut Universitarie de Cardiologie et de Pneumologie de Quebec.
A location was updated in Sherbrooke.
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The overall status was updated to "Recruiting" at Centre hospitalier universitaire de Sherbrooke.
20 May '16
The description was updated.
New
This is a prospective, open-label, randomized trial to investigate whether a strategy of ongoing, long-term oral anticoagulation with rivaroxaban 15 mg daily is superior to a strategy of antiplatelet therapy, ASA 75-160 mg, alone in preventing cerebral embolic events in moderately high risk patients following successful catheter ablation for atrial fibrillation.. At least one year post-successful catheter ablation for AF or left atrial flutter/tachycardia without evidence of any clinically apparent arrhythmia recurrence based on at least one 24 hour Holter and ECG within 6 months after the last ablation procedure and at least one 24 hour Holter and ECG between 6 and 12 months post-ablation or beyond. Patient must have no atrial fibrillation, atrial flutter or atrial tachycardia > 30 seconds detected on a minimum 48 hour Holter monitor within two months prior to enrollment. Patients will be randomized in a 1:1 fashion to ASA 75-160 mg daily or rivaroxaban 15 mg daily. Patients will be seen at 6 months, one year and every year thereafter for a minimum of 3 years. Blood chemistry tests, ECG, holters and patient quality of life questionnaires will be done annually. Cerebral MRI scanning at baseline, at year one and at three years will be done for assessment of silent cerebral infarction. MRI imaging will be performed using a specific protocol. A pre-specified subset of patients will undergo insertion of a implantable loop recorder (ILR) capable of automated AF detection.
Old
This is a prospective, open-label, randomized trial to investigate whether a strategy of ongoing, long-term oral anticoagulation with rivaroxaban 20 mg daily is superior to a strategy of antiplatelet therapy, ASA 81 mg, alone in preventing cerebral embolic events in moderately high risk patients following successful catheter ablation for atrial fibrillation.. Patients 12 months or more post-successful AF ablation will be screened for recurrent AF, atrial flutter (AFL) or atrial tachycardia (AT) of greater than 30 sec using holter monitors and ECG. Further screening for non-clinically apparent AF will be performed using 7 day holter monitors within one month of randomization. Only patient with less than or equal to 30 sec of AF, AFL mor AT will be eligible for randomization. Patients will be randomized in a 1:1 fashion to ASA 81 mg daily or rivaroxaban 20 mg daily. Patients will be seen at 6 months, one year and every year thereafter for a minimum of 3 years. Blood chemistry tests, ECG, holters and patient quality of life questionnaires will be done annually. Cerebral MRI scanning at baseline and at three years will be done for assessment of silent cerebral infarction. MRI imaging will be performed using a specific protocol. A pre-specified subset of patients will undergo insertion of a implantable loop recorder (ILR) capable of automated AF detection.
The minimum age criteria for eligibility was updated to "18 Years."
The eligibility criteria were updated.
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Inclusion Criteria: 1. At least one year post-successful catheter ablation for AF or left atrial flutter/tachycardia without evidence of any clinically apparent arrhythmia recurrence based on at least one 24 hour Holter and ECG within 6 months after the last ablation procedure and at least one 24 hour Holter and ECG between 6 and 12 months post-ablation or beyond. 2. Patient must have no atrial fibrillation, atrial flutter or atrial tachycardia > 30 seconds detected on a minimum 48 hour Holter monitor within two months prior to enrollment. 3. CHA2DS2-VASc risk score of 1 or more excluding patients in whom female sex or vascular disease are their sole risk factor. 4. Patients must be > 18 years of age. Exclusion Criteria 1. does not meet all of the above listed inclusion criteria. 2. unable or unwilling to provide informed consent. 3. included in another clinical trial 4. GFR < 30 mL/min 5. contraindication to oral anticoagulation (OAC) 6. contraindication to magnetic resonance imaging (MRI) 7. metallic prosthetic heart valve 8. non-arrhythmic condition necessitating long-term OAC 9. stroke within one year prior to enrolment
Old
Inclusion Criteria: - At least one year post-successful catheter ablation for AF or left atrial arrhythmia. Successful AF ablation is defined as no AF/AFL/AT >30 seconds on any pre-enrolment monitoring - CHADS2 risk score of 1 or more. Patients with CHADS2 score of 0, but who are >65 years old, or who are female with vascular disease will also be included - > 18 years of age Exclusion Criteria: - does not meet all of the above listed inclusion criteria. - unable or unwilling to provide informed consent. - included in another clinical trial - GFR < 30 mL/min - contraindication to oral anticoagulation (OAC) - metallic prosthetic heart valve - non-arrhythmic condition necessitating long-term OAC - stroke within one year prior to enrolment
A location was updated in Newmarket.
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The overall status was updated to "Recruiting" at Southlake Regional Health Centre.
17 Nov '15
The description was updated.
New
This is a prospective, open-label, randomized trial to investigate whether a strategy of ongoing, long-term oral anticoagulation with rivaroxaban 20 mg daily is superior to a strategy of antiplatelet therapy, ASA 81 mg, alone in preventing cerebral embolic events in moderately high risk patients following successful catheter ablation for atrial fibrillation.. Patients 12 months or more post-successful AF ablation will be screened for recurrent AF, atrial flutter (AFL) or atrial tachycardia (AT) of greater than 30 sec using holter monitors and ECG. Further screening for non-clinically apparent AF will be performed using 7 day holter monitors within one month of randomization. Only patient with less than or equal to 30 sec of AF, AFL mor AT will be eligible for randomization. Patients will be randomized in a 1:1 fashion to ASA 81 mg daily or rivaroxaban 20 mg daily. Patients will be seen at 6 months, one year and every year thereafter for a minimum of 3 years. Blood chemistry tests, ECG, holters and patient quality of life questionnaires will be done annually. Cerebral MRI scanning at baseline and at three years will be done for assessment of silent cerebral infarction. MRI imaging will be performed using a specific protocol. A pre-specified subset of patients will undergo insertion of a implantable loop recorder (ILR) capable of automated AF detection.
Old
This is a prospective, open-label, randomized trial to investigate whether a strategy of ongoing, long-term oral anticoagulation with rivaroxaban 20 mg daily is superior to a strategy of antiplatelet therapy, ASA 81 mg, alone in preventing cerebral embolic events in moderately high risk patients following successful catheter ablation for atrial fibrillation.. Patients 12 months or more post-successful AF ablation will be screened for recurrent AF, atrial flutter (AFL) or atrial tachycardia (AT) of greater than 30 sec using holter monitors and ECG. Further screening for non-clinically apparent AF will be performed using 7 day holter monitors within one month of randomization. Only patient with less than or equal to 30 sec of AF, AFL mor AT will be eligible for randomization. Patients will be randomized in a 1:1 fashion to ASA 81 mg daily or rivaroxaban 20 mg daily. Patients will be seen at 6 months, one year and every year thereafter for a minimum of 3 years. Blood chemistry tests, ECG, holters and patient quality of life questionnaires will be done annually. Cerebral MRI scanning at baseline and at three years will be done for assessment of silent cerebral infarction. MRI imaging will be performed using a specific protocol. A pre-specified subset of patients will undergo insertion of a implantable loop recorder (ILR) capable of automated AF detection.
The eligibility criteria were updated.
New
Inclusion Criteria: - At least one year post-successful catheter ablation for AF or left atrial arrhythmia. Successful AF ablation is defined as no AF/AFL/AT >30 seconds on any pre-enrolment monitoring - CHADS2 risk score of 1 or more. Patients with CHADS2 score of 0, but who are >65 years old, or who are female with vascular disease will also be included - > 18 years of age Exclusion Criteria: - does not meet all of the above listed inclusion criteria. - unable or unwilling to provide informed consent. - included in another clinical trial - GFR < 30 mL/min - contraindication to oral anticoagulation (OAC) - metallic prosthetic heart valve - non-arrhythmic condition necessitating long-term OAC - stroke within one year prior to enrolment
Old
Inclusion Criteria: - At least one year post-successful catheter ablation for AF or left atrial arrhythmia. Successful AF ablation is defined as no AF/AFL/AT >30 seconds on any pre-enrolment monitoring - CHADS2 risk score of 1 or more. Patients with CHADS2 score of 0, but who are >65 years old, or who are female with vascular disease will also be included - > 18 years of age Exclusion Criteria: - does not meet all of the above listed inclusion criteria. - unable or unwilling to provide informed consent. - included in another clinical trial - GFR < 30 mL/min - contraindication to oral anticoagulation (OAC) - metallic prosthetic heart valve - non-arrhythmic condition necessitating long-term OAC - stroke within one year prior to enrolment