Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

Phase 3

Completed

Brief Summary: This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.

Recruitment & Eligibility

Inclusion Criteria

Paroxysmal, persistent or permanent non-valvular AF
Eligible for long-term warfarin therapy
Eligible to come off warfarin therapy
Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:
- Female age 75 or older
- Baseline LVEF ≥ 30 and < 35%
- Aged 65-74 and has diabetes or coronary artery disease
- Aged 65 or greater and has congestive heart failure

Key

Exclusion Criteria

Contraindicated/allergic to aspirin
Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
History of atrial septal repair or has an ASD/PFO device
Implanted mechanical valve prosthesis
NYHA Class IV CHF
Resting heart rate > 110 bpm
Participated previously in the PROTECT AF or CAP Registry studies

Key Echo Exclusion Criteria:

Arm && Interventions

Group	Intervention	Description
WATCHMAN	WATCHMAN Device	Subjects assigned to receive the WATCHMAN device.
Warfarin	Warfarin	Subjects assigned to warfarin therapy.

Primary Outcome Measures

Name	Time	Method
Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)	18 month rate	The endpoint was analyzed using a Bayesian piecewise exponential model with the historical priors based on data from the previous pivotal study PROTECT AF. This was a non-inferiority design with comparison of rate ratio of 18-month event rates of the Device and Control groups. The 18-month rate represents the probability of an event occurring within 18 months, and the 18-month rate ratio is a mean of the rate ratios. The primary endpoint was based on a calculation of the probability of events at 18 months but the statistical piecewise hazards model does not require the observation of any subjects out to 18-months.
Composite of Ischemic Stroke or Systemic Embolism	Day 8 to 18-months	Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization
Primary Safety Endpoint (Device Group Only)	7-Day	7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.

Secondary Outcome Measures

Name	Time	Method

Locations (40): Mercy Gilbert Medical Center
🇺🇸
Gilbert, Arizona, United States
Arizona Heart Rhythm Research Center
🇺🇸
Scottsdale, Arizona, United States
Foundation for Cardiovascular Medicine
🇺🇸
La Jolla, California, United States
Scripps Green
🇺🇸
La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Orange County Heart
🇺🇸
Orange, California, United States
St. John's Hospital / Pacific Heart
🇺🇸
Santa Monica, California, United States
Zasa Clinical Research
🇺🇸
Atlantis, Florida, United States
Baptist Hospital of Miami
🇺🇸
Miami, Florida, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Scroll for more (30 remaining)
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States