This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.
- Warfarin (Coumadin®)Drug
Intervention Desc: Subjects receive warfarin ARM 1: Kind: Experimental Label: Warfarin control Description: Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
- WATCHMAN® device Other
Intervention Desc: The WATCHMAN® device is designed to keep harmful sized blood clots that form in the left atrial appendage from entering your blood stream, potentially causing a stroke. It is made of materials that are common to many medical devices. The WATCHMAN device is designed to be permanently placed just behind or at the opening of the left atrial appendage.
- WATCHMAN Left Atrial Appendage Closure Technology Device
Other Names: WATCHMAN Intervention Desc: Implant of WATCHMAN Left Atrial Appendage Closure Technology ARM 1: Kind: Experimental Label: Implantable device Description: Implantable WATCHMAN Left ATrial Appendage Occlusion Device ARM 2: Kind: Experimental Label: WATCHMAN Description: Implant of WATCHMAN Left Atrial Appendage Closure Technology ARM 3: Kind: Experimental Label: Roll-in Description: Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Baseline testing for patients consists of medical history, TEE and coagulation testing. Follow-up of patients will be done at 45 days, 6, 9, and 12 months and semi-annually thereafter.
|Type||Measure||Time Frame||Safety Issue|
|Primary||All stroke; systemic embolism; cardiovascular mortality.|
|Secondary||Technical success; procedure success; 30 day major adverse event (MAE); left atrial appendage (LAA) coverage.|
|Primary||All stroke||5 years||Yes|
|Primary||Systemic embolism||5 years||No|
|Primary||Cardiovascular death||5 years||No|
|Secondary||Technical success||45 days||No|
|Secondary||Procedure success||45 days||No|
|Secondary||30 day major adverse event (MAE)||30 days||Yes|
|Secondary||Left atrial appendage (LAA) coverage||45 days||No|
|Primary||Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death||5 years||No|
|Primary||The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events||5 years||Yes|