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Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)

Primary Purpose

Atrial Fibrillation, Stroke

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
WATCHMAN Device
Warfarin
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, stroke, TIA, trans ischemic attack, warfarin, Coumadin

Eligibility Criteria

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

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Key Echo Exclusion Criteria:

  • 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

Sites / Locations

  • Mercy Gilbert Medical Center
  • Arizona Heart Rhythm Research Center
  • Foundation for Cardiovascular Medicine
  • Scripps Green
  • Cedars-Sinai Medical Center
  • Orange County Heart
  • St. John's Hospital / Pacific Heart
  • Zasa Clinical Research
  • Baptist Hospital of Miami
  • Florida Hospital
  • Emory University
  • North Shore University
  • Iowa Heart Center
  • Central Baptist Hospital
  • Massachusetts General Hospital
  • Lahey Clinic
  • University of Michigan Medical Center
  • William Beaumont
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • Cardiology Associates of N. Mississippi
  • St. Luke's Hospital
  • St. John's Mercy
  • Bryan LGH
  • Englewood Hospital and Medical Center
  • New York University Medical Center
  • Mt. Sinai School of Medicine
  • Columbia University Medical Center
  • Carolinas Medical Center
  • Lindner Clinical Trial Center
  • Cleveland Clinic
  • Hospital of the University of Pennsylvania
  • Moffitt Heart & Vascular
  • St. Thomas Research Institute
  • Texas Cardiac Arrhythmia
  • Baylor Research Institute
  • Methodist Hospital
  • Intermountain Medical Center
  • Fletcher Allen
  • Swedish Medical Center
  • St. Luke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WATCHMAN

Warfarin

Arm Description

Subjects assigned to receive the WATCHMAN device.

Subjects assigned to warfarin therapy.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint (Device Group Only)
7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
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.
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

Secondary Outcome Measures

Full Information

First Posted
August 12, 2010
Last Updated
July 25, 2018
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01182441
Brief Title
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Acronym
PREVAIL
Official Title
Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
November 2017 (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 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.

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, stroke, TIA, trans ischemic attack, warfarin, Coumadin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WATCHMAN
Arm Type
Experimental
Arm Description
Subjects assigned to receive the WATCHMAN device.
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Subjects assigned to warfarin therapy.
Intervention Type
Device
Intervention Name(s)
WATCHMAN Device
Intervention Description
WATCHMAN Left Atrial Appendage Closure Technology
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Primary Outcome Measure Information:
Title
Primary Safety Endpoint (Device Group Only)
Description
7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
Time Frame
7-Day
Title
Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)
Description
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.
Time Frame
18 month rate
Title
Composite of Ischemic Stroke or Systemic Embolism
Description
Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization
Time Frame
Day 8 to 18-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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 Key Echo Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Holmes, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vivek Y. Reddy, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Arizona Heart Rhythm Research Center
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
Scripps Green
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Orange County Heart
City
Orange
State/Province
California
ZIP/Postal Code
92868
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
Zasa Clinical Research
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
North Shore University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
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
Cardiology Associates of N. Mississippi
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Bryan LGH
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
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
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
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
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Moffitt Heart & Vascular
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
St. Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Cardiac Arrhythmia
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Methodist 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
Fletcher Allen
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
St. Luke's Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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
35512918
Citation
Friedman 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. Erratum In: JACC Cardiovasc Interv. 2022 Aug 22;15(16):1693.
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

Learn more about this trial

Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

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