WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
1 other identifier
interventional
800
3 countries
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 atrial-fibrillation
Started Feb 2005
Longer than P75 for phase_2 atrial-fibrillation
62 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
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 10, 2005
CompletedFirst Posted
Study publicly available on registry
August 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
May 15, 2015
CompletedMay 15, 2015
April 1, 2015
8.5 years
August 10, 2005
October 3, 2014
April 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
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)
5 years
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
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.
5 years
Secondary Outcomes (1)
Procedure Success
Initial implant procedure
Study Arms (3)
WATCHMAN
EXPERIMENTALImplant of WATCHMAN Left Atrial Appendage Closure Technology
Warfarin control
ACTIVE COMPARATORSubjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Roll-in
OTHERImplant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
Interventions
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Eligibility Criteria
You may qualify if:
- Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
- Eligible for long term warfarin
- CHADS score \>= 1 \[congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)\]
You may not qualify if:
- Contraindicated for warfarin
- Contraindicated for aspirin or clopidogrel (Plavix)
- Congestive heart failure (CHF) Class 4
- Implanted mechanical valve
- Atrial septal or Patent Foramen Ovale (PFO) device
- Platelets \< 100,000 or hemoglobin \< 10
- Left ventricular ejection fraction (LVEF) \< 30%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Advanced Cardiac Specialists
Gilbert, Arizona, 85233, United States
Arizona Arrhythmia
Scottsdale, Arizona, 85251, United States
Foundation for Cardiovascular Medicine
La Jolla, California, 92037, United States
Los Angeles Cardiology Associates
Los Angeles, California, 90017, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
El Camino Hospital
Mountain View, California, 94040, United States
Orange County Heart
Orange County, California, 92868, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
St. John's Hospital / Pacific Heart
Santa Monica, California, 90404, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Miami
Miami, Florida, 33136, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Bay Heart Group
Tampa, Florida, 33607, United States
Emory University Midtown Hospital
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
North Shore University
Evanston, Illinois, 60201, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Prairie Education Research Cooperative
Springfield, Illinois, 60637, United States
Baptist Hospital West
Lexington, Kentucky, 40503, United States
University of Kentucky
Lexington, Kentucky, 40536-0294, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, 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
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102, United States
University of Mississippi Healthcare Center
Jackson, Mississippi, 39216, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
New York University Medical Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Mt. Sinai Medical Center
New York, New York, United States
Summa Health System
Akron, Ohio, 44304, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Harrisburg Hospital / Associated Cardiology
Harrisburg, Pennsylvania, 17110, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Presbyterian University Hospital
Pittsburgh, Pennsylvania, 15213, United States
Moffitt Heart & Vascular
Wormleysburg, Pennsylvania, 17043, United States
Mercy Medical Center West
Knoxville, Tennessee, 37934, United States
St. Thomas Research Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, 78705, United States
St. Lukes Episcopal Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Salt Lake City, Utah, 84107, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Na Homolce
Prague, 15030, Czechia
Krankenhaus der Barmherzige Bruder
Regensburg, Bavaria, 93049, Germany
Cardiovasculares Centrum Frankfurt - Sankt Katharinen
Frankfurt am Main, Hesse, 60389, Germany
Herzzentrum
Leipzig, Germany
Related Publications (8)
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: 35902169DERIVEDBrouwer 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: 26627989DERIVEDReddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
PMID: 25399274DERIVEDAlli O, Doshi S, Kar S, Reddy V, Sievert H, Mullin C, Swarup V, Whisenant B, Holmes D Jr. Quality of life assessment in the randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of patients at risk for stroke with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2013 Apr 30;61(17):1790-8. doi: 10.1016/j.jacc.2013.01.061. Epub 2013 Feb 28.
PMID: 23500276DERIVEDReddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
PMID: 23325525DERIVEDReddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011 Feb 1;123(4):417-24. doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.
PMID: 21242484DERIVEDHolmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.
PMID: 19683639DERIVED
Related Links
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 Holmes, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2005
First Posted
August 12, 2005
Study Start
February 1, 2005
Primary Completion
August 1, 2013
Study Completion
May 1, 2014
Last Updated
May 15, 2015
Results First Posted
May 15, 2015
Record last verified: 2015-04