Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

Recruiting

Phase N/A Results N/A

Update History

7 Jul '17
The eligibility criteria were updated.
New
Inclusion Criteria: - Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days - Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up - Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke: - Congestive heart failure - Hypertension (Systolic Blood Pressure > 140) - Diabetes Mellitus - Prior Stroke (>90 days ago, other than study qualifying index event) - Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque) Exclusion Criteria: - Subject has had a cryptogenic stroke - Subject has had a cardioembolic stroke - Subject has untreated hyperthyroidism - Subject has had a recent myocardial infarction <1 month of stroke - Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke - Subject has a mechanical heart valve - Subject has valvular disease requiring immediate surgical intervention - Subject has documented prior history of atrial fibrillation or atrial flutter - Subject has permanent indication for oral anticoagulation - Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment - Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee. - Subject's life expectancy is less than 1 year - Subject is pregnant - Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor - Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
Old
Inclusion Criteria: - Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days - Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up - Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke: - Congestive heart failure - Hypertension (Systolic Blood Pressure > 140) - Diabetes Mellitus - Prior Stroke (>90 days ago, other than study qualifying index event) - Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque) Exclusion Criteria: - Subject has had a cryptogenic stroke - Subject has had a cardioembolic stroke - Subject has untreated hyperthyroidism - Subject has had a recent myocardial infarction <1 month of stroke - Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke - Subject has a mechanical heart valve - Subject has valvular disease requiring immediate surgical intervention - Subject has documented prior history of atrial fibrillation or atrial flutter - Subject has permanent indication for oral anticoagulation - Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment - Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee. - Subject's life expectancy is less than 1 year - Subject is pregnant - Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor - Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
21 Apr '17
Trial name was updated.
New
Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Trial was updated to "N/A."
The gender criteria for eligibility was updated to "All."
13 Sep '16
A location was updated in Mounds View.
New
The overall status was updated to "Recruiting" at Medtronic, Inc.
19 Mar '16
Trial name was updated.
New
Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
The description was updated.
New
Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.
Old
Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of AF through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ ICM inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.
The eligibility criteria were updated.
New
Inclusion Criteria: - Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days - Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up - Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke: - Congestive heart failure - Hypertension (Systolic Blood Pressure > 140) - Diabetes Mellitus - Prior Stroke (>90 days ago, other than study qualifying index event) - Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque) Exclusion Criteria: - Subject has had a cryptogenic stroke - Subject has had a cardioembolic stroke - Subject has untreated hyperthyroidism - Subject has had a recent myocardial infarction <1 month of stroke - Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke - Subject has a mechanical heart valve - Subject has valvular disease requiring immediate surgical intervention - Subject has documented prior history of atrial fibrillation or atrial flutter - Subject has permanent indication for oral anticoagulation - Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment - Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee. - Subject's life expectancy is less than 1 year - Subject is pregnant - Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor - Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
Old
Inclusion Criteria: - Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days - Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up - Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke: - Congestive heart failure - Hypertension (Systolic Blood Pressure > 140) - Diabetes Mellitus - Prior Stroke (>90 days ago, other than study qualifying index event) - Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque) Exclusion Criteria: - Subject has had a cryptogenic stroke - Subject has had a cardioembolic stroke - Subject has untreated hyperthyroidism - Subject has had a recent myocardial infarction <1 month of stroke - Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke - Subject has a mechanical heart valve - Subject has valvular disease requiring immediate surgical intervention - Subject has documented prior history of atrial fibrillation or atrial flutter - Subject has permanent indication for oral anticoagulation - Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment - Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee. - Subject's life expectancy is less than 1 year - Subject is pregnant - Subject has or is indicated for implant with a pacemaker, ICD, CRT, or an implantable hemodynamic monitor - Subject with a medical condition that precludes the patient from participation in the opinion of the investigator