WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

Stroke Clinical Trial

Official title:

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129545
• Other study ID #: ST1021 and ST1055
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 10, 2005
• Last updated: April 29, 2015
• Start date: February 2005
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: May 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Device:
• WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology

Drug:
• Warfarin
Subjects receive warfarin

Locations

Country	Name	City	State
Czech Republic	Na Homolce	Prague
Germany	Cardiovasculares Centrum Frankfurt - Sankt Katharinen	Frankfurt am Main	Hessen
Germany	Herzzentrum	Leipzig
Germany	Krankenhaus der Barmherzige Bruder	Regensburg	Bayern
United States	Summa Health System	Akron	Ohio
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Midtown Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	North Shore University	Evanston	Illinois
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Advanced Cardiac Specialists	Gilbert	Arizona
United States	Harrisburg Hospital / Associated Cardiology	Harrisburg	Pennsylvania
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	St. Lukes Episcopal Hospital	Houston	Texas
United States	University of Mississippi Healthcare Center	Jackson	Mississippi
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Mercy Medical Center West	Knoxville	Tennessee
United States	Foundation for Cardiovascular Medicine	La Jolla	California
United States	Baptist Hospital West	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Los Angeles Cardiology Associates	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	El Camino Hospital	Mountain View	California
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	New York University Medical Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Orange County Heart	Orange County	California
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Presbyterian University Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont	Royal Oak	Michigan
United States	UC Davis Medical Center	Sacramento	California
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	St. John's Hospital / Pacific Heart	Santa Monica	California
United States	Arizona Arrhythmia	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Prairie Education Research Cooperative	Springfield	Illinois
United States	St. Paul Heart Clinic	St. Paul	Minnesota
United States	Bay Heart Group	Tampa	Florida
United States	Washington Hospital Center	Washington	District of Columbia
United States	Moffitt Heart & Vascular	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Procedure Success	Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.	Initial implant procedure	No

External Links

•   Sponsor website