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

Stroke Clinical Trial

— PREVAIL  

Official title:

Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182441
• Other study ID #: CT1004
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: November 2017

Study information

• Verified date: March 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: November 2017
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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:

• LVEF < 30%

• Existing pericardial effusion > 2mm

• High risk PFO

• Significant mitral valve stenosis

• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch

• Cardiac tumor

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Device:
• WATCHMAN Device
WATCHMAN Left Atrial Appendage Closure Technology

Drug:
• Warfarin
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Zasa Clinical Research	Atlantis	Florida
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Fletcher Allen	Burlington	Vermont
United States	Lahey Clinic	Burlington	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	Iowa Heart Center	Des Moines	Iowa
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	North Shore University	Evanston	Illinois
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Methodist Hospital	Houston	Texas
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Foundation for Cardiovascular Medicine	La Jolla	California
United States	Scripps Green	La Jolla	California
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Bryan LGH	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Baptist Hospital of Miami	Miami	Florida
United States	St. Luke's Hospital	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Mt. Sinai School of Medicine	New York	New York
United States	New York University Medical Center	New York	New York
United States	Orange County Heart	Orange	California
United States	Florida Hospital	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont	Royal Oak	Michigan
United States	St. John's Mercy	Saint Louis	Missouri
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	St. John's Hospital / Pacific Heart	Santa Monica	California
United States	Arizona Heart Rhythm Research Center	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Cardiology Associates of N. Mississippi	Tupelo	Mississippi
United States	Moffitt Heart & Vascular	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint (Device Group Only)	7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.	7-Day
Primary	Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)	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.	18 month rate
Primary	Composite of Ischemic Stroke or Systemic Embolism	Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization	Day 8 to 18-months