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

Primary Purpose

Atrial Fibrillation, Stroke

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
WATCHMAN Left Atrial Appendage Closure Technology
Warfarin
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Blood thinning medication, transient ischemic attack (TIA), WATCHMAN, Left atrial appendage, LAA isolation, LAA occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Advanced Cardiac Specialists
  • Arizona Arrhythmia
  • Foundation for Cardiovascular Medicine
  • Los Angeles Cardiology Associates
  • Cedars-Sinai Medical Center
  • El Camino Hospital
  • Orange County Heart
  • UC Davis Medical Center
  • St. John's Hospital / Pacific Heart
  • Washington Hospital Center
  • University of Miami
  • Baptist Cardiac and Vascular Institute
  • Bay Heart Group
  • Emory University Midtown Hospital
  • Piedmont Hospital
  • Emory University Hospital
  • University of Chicago
  • North Shore University
  • Loyola University Medical Center
  • Prairie Education Research Cooperative
  • Baptist Hospital West
  • University of Kentucky
  • Terrebonne General Medical Center
  • Ochsner Clinic
  • Massachusetts General Hospital
  • University of Michigan Medical Center
  • William Beaumont
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • St. Paul Heart Clinic
  • University of Mississippi Healthcare Center
  • St. Luke's Hospital
  • Nebraska Heart Institute
  • Cooper University Hospital
  • New Mexico Heart Institute
  • New York University Medical Center
  • Columbia University Medical Center
  • Mt. Sinai Medical Center
  • Summa Health System
  • Lindner Clinical Trial Center
  • Cleveland Clinic Foundation
  • Ohio State University
  • Riverside Methodist Hospital
  • Geisinger Medical Center
  • Harrisburg Hospital / Associated Cardiology
  • Allegheny General Hospital
  • Presbyterian University Hospital
  • Moffitt Heart & Vascular
  • Mercy Medical Center West
  • St. Thomas Research Institute
  • Texas Cardiac Arrhythmia
  • St. Lukes Episcopal Hospital
  • Intermountain Medical Center
  • University of Virginia
  • Inova Fairfax Hospital
  • Sentara Norfolk General Hospital
  • Swedish Medical Center
  • Marshfield Clinic
  • Na Homolce
  • Krankenhaus der Barmherzige Bruder
  • Cardiovasculares Centrum Frankfurt - Sankt Katharinen
  • Herzzentrum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

WATCHMAN

Warfarin control

Roll-in

Arm Description

Implant of WATCHMAN Left Atrial Appendage Closure Technology

Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin

Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Procedure Success
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Full Information

First Posted
August 10, 2005
Last Updated
April 29, 2015
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00129545
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WATCHMAN
Arm Type
Experimental
Arm Description
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Arm Title
Warfarin control
Arm Type
Active Comparator
Arm Description
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Arm Title
Roll-in
Arm Type
Other
Arm Description
Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
Intervention Type
Device
Intervention Name(s)
WATCHMAN Left Atrial Appendage Closure Technology
Other Intervention Name(s)
WATCHMAN
Intervention Description
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Subjects receive warfarin
Primary Outcome Measure Information:
Title
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
Description
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)
Time Frame
5 years
Title
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Procedure Success
Description
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
Time Frame
Initial implant procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Holmes, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Cardiac Specialists
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85233
Country
United States
Facility Name
Arizona Arrhythmia
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Foundation for Cardiovascular Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Los Angeles Cardiology Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Orange County Heart
City
Orange County
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
St. John's Hospital / Pacific Heart
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Bay Heart Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Emory University Midtown Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
North Shore University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Prairie Education Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Baptist Hospital West
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0294
Country
United States
Facility Name
Terrebonne General Medical Center
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
William Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
St. Paul Heart Clinic
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Mississippi Healthcare Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Harrisburg Hospital / Associated Cardiology
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Presbyterian University Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Moffitt Heart & Vascular
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Mercy Medical Center West
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
St. Thomas Research Institute
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Cardiac Arrhythmia
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St. Lukes Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Na Homolce
City
Prague
ZIP/Postal Code
15030
Country
Czech Republic
Facility Name
Krankenhaus der Barmherzige Bruder
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93049
Country
Germany
Facility Name
Cardiovasculares Centrum Frankfurt - Sankt Katharinen
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60389
Country
Germany
Facility Name
Herzzentrum
City
Leipzig
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35902169
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.
Results Reference
derived
PubMed Identifier
31752643
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.
Results Reference
derived
PubMed Identifier
26627989
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.
Results Reference
derived
PubMed Identifier
25399274
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. Erratum In: JAMA. 2015 Mar 10;313(10):1061.
Results Reference
derived
PubMed Identifier
23500276
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.
Results Reference
derived
PubMed Identifier
23325525
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.
Results Reference
derived
PubMed Identifier
21242484
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.
Results Reference
derived
PubMed Identifier
19683639
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. Erratum In: Lancet. 2009 Nov 7;374(9701):1596.
Results Reference
derived
Links:
URL
http://www.atritech.net
Description
Sponsor website

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

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