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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01182441
First received: August 12, 2010
Last updated: September 23, 2013
Last verified: March 2013

August 12, 2010
September 23, 2013
November 2010
December 2013   (final data collection date for primary outcome measure)
Primary Endpoints [ Time Frame: 18 month rates ] [ Designated as safety issue: Yes ]
7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention; Comparison of the composite of stroke, systemic embolism and cardiovascular/unexplained death; Comparison of ischemic stroke and systemic embolism occurring greater than 7 days post randomization.
Primary Efficacy Endpoint [ Time Frame: 6-Months ] [ Designated as safety issue: Yes ]
The occurance of stroke, cardiovascular death and systemic embolism.
Complete list of historical versions of study NCT01182441 on ClinicalTrials.gov Archive Site
Predefined Additional Analyses [ Time Frame: 18 month rates and acute procedure rates ] [ Designated as safety issue: Yes ]
Device and procedure related events; Mortality; New versus experienced operators; Sensitivity analyses for post procedure population, per protocol #1 population and per protocol #2 population
Not Provided
Not Provided
Not Provided
 
Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.

The PREVAIL study was amended to initiate a prospective, non-randomized continued access study titled "Continued Access to PREVAIL (CAP2)" to collect additional information on the safety and efficacy of the WATCHMAN LAA closure technology. The study is estimated to enroll an initial cohort of 300 subjects with a maximum of 1500 subjects, at 60 investigational sites in the U.S.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Stroke
  • 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
  • Experimental: WATCHMAN
    Subjects assigned to receive the WATCHMAN device.
    Intervention: Device: WATCHMAN Device
  • Active Comparator: Warfarin
    Subjects assigned to warfarin therapy.
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
475
June 2017
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01182441
CT1004
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: David R. Holmes, M.D. Mayo Clinic
Principal Investigator: Vivek Y. Reddy, M.D. Mount Sinai School of Medicine
Boston Scientific Corporation
March 2013

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