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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182441
First Posted: August 16, 2010
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Boston Scientific Corporation
August 12, 2010
August 16, 2010
October 12, 2017
November 2010
January 2013   (Final data collection date for primary outcome measure)
Primary Endpoints [ Time Frame: 18 month rates ]
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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Price MJ, Reddy VY, Valderrábano 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
475
August 2017
January 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01182441
CT1004
Yes
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: David R. Holmes, M.D. Mayo Clinic
Principal Investigator: Vivek Y. Reddy, M.D. Icahn School of Medicine at Mount Sinai
Boston Scientific Corporation
March 2013

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