Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
PREVAIL
Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
1 other identifier
interventional
407
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Nov 2010
Longer than P75 for phase_3 atrial-fibrillation
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2010
CompletedFirst Posted
Study publicly available on registry
August 16, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedResults Posted
Study results publicly available
July 26, 2018
CompletedJuly 26, 2018
March 1, 2017
2.2 years
August 12, 2010
April 3, 2017
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
WATCHMAN
EXPERIMENTALSubjects assigned to receive the WATCHMAN device.
Warfarin
ACTIVE COMPARATORSubjects assigned to warfarin therapy.
Interventions
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Arizona Heart Rhythm Research Center
Scottsdale, Arizona, 85251, United States
Foundation for Cardiovascular Medicine
La Jolla, California, 92037, United States
Scripps Green
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Orange County Heart
Orange, California, 92868, United States
St. John's Hospital / Pacific Heart
Santa Monica, California, 90404, United States
Zasa Clinical Research
Atlantis, Florida, 33462, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Florida Hospital
Orlando, Florida, 32803, United States
Emory University
Atlanta, Georgia, 30308, United States
North Shore University
Evanston, Illinois, 60201, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
William Beaumont
Royal Oak, Michigan, 48073, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Cardiology Associates of N. Mississippi
Tupelo, Mississippi, 38801, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
St. John's Mercy
St Louis, Missouri, 63141, United States
Bryan LGH
Lincoln, Nebraska, 68506, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
New York University Medical Center
New York, New York, 10016, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Moffitt Heart & Vascular
Wormleysburg, Pennsylvania, 17043, United States
St. Thomas Research Institute
Nashville, Tennessee, 37203, United States
Texas Cardiac Arrhythmia
Austin, Texas, 78705, United States
Baylor Research Institute
Dallas, Texas, 75226, United States
Methodist Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Salt Lake City, Utah, 84107, United States
Fletcher Allen
Burlington, Vermont, 05401, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
St. Luke's Hospital
Milwaukee, Wisconsin, 53215, United States
Related Publications (4)
Dukkipati SR, Holmes DR Jr, Doshi SK, Kar S, Singh SM, Gibson D, Price MJ, Natale A, Mansour M, Sievert H, Houle VM, Allocco DJ, Reddy VY. Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure. J Am Coll Cardiol. 2022 Aug 2;80(5):469-483. doi: 10.1016/j.jacc.2022.04.062.
PMID: 35902169DERIVEDFriedman DJ, Du C, Wang Y, Agarwal V, Varosy PD, Masoudi FA, Holmes DR, Reddy VY, Price MJ, Curtis JP, Freeman JV. Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials. JACC Cardiovasc Interv. 2022 May 9;15(9):950-961. doi: 10.1016/j.jcin.2022.02.029.
PMID: 35512918DERIVEDBrouwer TF, Whang W, Kuroki K, Halperin JL, Reddy VY. Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies. J Am Heart Assoc. 2019 Dec 3;8(23):e013525. doi: 10.1161/JAHA.119.013525. Epub 2019 Nov 22.
PMID: 31752643DERIVEDPrice MJ, Reddy VY, Valderrabano M, Halperin JL, Gibson DN, Gordon N, Huber KC, Holmes DR Jr. Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience. JACC Cardiovasc Interv. 2015 Dec 28;8(15):1925-1932. doi: 10.1016/j.jcin.2015.08.035. Epub 2015 Nov 25.
PMID: 26627989DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- WATCHMAN Trial Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
David R. Holmes, M.D.
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Vivek Y. Reddy, M.D.
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2010
First Posted
August 16, 2010
Study Start
November 1, 2010
Primary Completion
January 1, 2013
Study Completion
November 1, 2017
Last Updated
July 26, 2018
Results First Posted
July 26, 2018
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share