WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

Phase 2

Completed

Interventions: Device: WATCHMAN Left Atrial Appendage Closure Technology
Drug: Warfarin

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
Eligible for long term warfarin
CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)]

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Roll-in	WATCHMAN Left Atrial Appendage Closure Technology	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.
WATCHMAN	WATCHMAN Left Atrial Appendage Closure Technology	Implant of WATCHMAN Left Atrial Appendage Closure Technology
Warfarin control	Warfarin	Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin

Primary Outcome Measures

Name	Time	Method
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death	5 years	A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years)
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events	5 years	Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.

Secondary Outcome Measures

Name	Time	Method
Procedure Success	Initial implant procedure	Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Locations (62): Advanced Cardiac Specialists
🇺🇸
Gilbert, Arizona, United States
Arizona Arrhythmia
🇺🇸
Scottsdale, Arizona, United States
Foundation for Cardiovascular Medicine
🇺🇸
La Jolla, California, United States
Los Angeles Cardiology Associates
🇺🇸
Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
El Camino Hospital
🇺🇸
Mountain View, California, United States
Orange County Heart
🇺🇸
Orange County, California, United States
UC Davis Medical Center
🇺🇸
Sacramento, California, United States
St. John's Hospital / Pacific Heart
🇺🇸
Santa Monica, California, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
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Advanced Cardiac Specialists
🇺🇸Gilbert, Arizona, United States