Clinical trial NCT00129545: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Official title: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atrial Fibrillation
Stroke
Keywords: Atrial Fibrillation
AF
A Fib
Stroke
Coumadin
Warfarin
Blood thinning medication
transient ischemic attack (TIA)
WATCHMAN
Left atrial appendage
LAA isolation
LAA occlusion
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

* 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%

Primary outcomes:
measure: Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
timeFrame: 5 years
measure: The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
timeFrame: 5 years
Secondary outcomes:
measure: Procedure Success
timeFrame: Initial implant procedure
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Advanced Cardiac Specialists
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia
state: Arizona
city: La Jolla
country: United States
facility: Foundation for Cardiovascular Medicine
state: California
city: Los Angeles
country: United States
facility: Los Angeles Cardiology Associates
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Orange County
country: United States
facility: Orange County Heart
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Santa Monica
country: United States
facility: St. John's Hospital / Pacific Heart
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Tampa
country: United States
facility: Bay Heart Group
state: Florida
city: Atlanta
country: United States
facility: Emory University Midtown Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: North Shore University
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education Research Cooperative
state: Illinois
city: Lexington
country: United States
facility: Baptist Hospital West
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Healthcare Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Harrisburg Hospital / Associated Cardiology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Presbyterian University Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Moffitt Heart & Vascular
state: Pennsylvania
city: Knoxville
country: United States
facility: Mercy Medical Center West
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Houston
country: United States
facility: St. Lukes Episcopal Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Prague
country: Czech Republic
facility: Na Homolce
city: Regensburg
country: Germany
facility: Krankenhaus der Barmherzige Bruder
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Cardiovasculares Centrum Frankfurt - Sankt Katharinen
state: Hessen
city: Leipzig
country: Germany
facility: Herzzentrum
Study officials:
affiliation: Mayo Clinic
name: David Holmes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Brouwer 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.
citation: Price 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.
citation: Reddy 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.
citation: Alli 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.
citation: Reddy 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.
citation: Reddy 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.
citation: Holmes 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.