Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01182441
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE August 12, 2010
First Posted Date  ICMJE August 16, 2010
Results First Submitted Date  ICMJE April 3, 2017
Results First Posted Date  ICMJE July 26, 2018
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE November 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • Primary Safety Endpoint (Device Group Only) [ Time Frame: 7-Day ]
    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) [ Time Frame: 18 month rate ]
    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 [ Time Frame: Day 8 to 18-months ]
    Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
Primary Efficacy Endpoint [ Time Frame: 6-Months ]
The occurance of stroke, cardiovascular death and systemic embolism.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Official Title  ICMJE Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Stroke
Intervention  ICMJE
  • Device: WATCHMAN Device
    WATCHMAN Left Atrial Appendage Closure Technology
  • Drug: Warfarin
    Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
    Other Name: Coumadin
Study Arms  ICMJE
  • Experimental: WATCHMAN
    Subjects assigned to receive the WATCHMAN device.
    Intervention: Device: WATCHMAN Device
  • Active Comparator: Warfarin
    Subjects assigned to warfarin therapy.
    Intervention: Drug: Warfarin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2018)
407
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2010)
475
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01182441
Other Study ID Numbers  ICMJE CT1004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David R. Holmes, M.D. Mayo Clinic
Principal Investigator: Vivek Y. Reddy, M.D. Icahn School of Medicine at Mount Sinai
PRS Account Boston Scientific Corporation
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP