Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02700945|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Device: Reveal LINQ™ Insertable Cardiac Monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||497 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized 1:1 to the continuous monitoring arm or the control arm. 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.|
|Masking:||None (Open Label)|
|Official Title:||Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||August 4, 2020|
|Estimated Study Completion Date :||December 2022|
Active Comparator: Reveal LINQ™ Insertable Cardiac Monitor
Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.
Device: Reveal LINQ™ Insertable Cardiac Monitor
The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.
No Intervention: Control Arm
Subjects randomized to the control arm will be followed per site specific standard of care.
- The primary objective is to compare the incidence rate of AF through 12 months between the continuous monitoring arm vs control arm in subjects with a recent ischemic stroke of presumed known origin. [ Time Frame: 12 months ]AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.
- To compare the incidence rates of AF through the duration of study follow-up between study arms. [ Time Frame: 3 years ]AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700945
|Study Chair:||Richard Bernstein, PhD/MD||Northwestern|
|Study Chair:||Lee Schwamm, MD||Mass General|