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Evaluation of the WATCHMAN 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 : Unknown
Verified March 2013 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
First Posted : August 16, 2010
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Device: WATCHMAN Device Drug: Warfarin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Study Start Date : November 2010
Primary Completion Date : January 2013
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: WATCHMAN
Subjects assigned to receive the WATCHMAN device.
Device: WATCHMAN Device
WATCHMAN Left Atrial Appendage Closure Technology
Active Comparator: Warfarin
Subjects assigned to warfarin therapy.
Drug: Warfarin
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Other Name: Coumadin


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182441


  Show 41 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: David R. Holmes, M.D. Mayo Clinic
Principal Investigator: Vivek Y. Reddy, M.D. Icahn School of Medicine at Mount Sinai
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01182441     History of Changes
Other Study ID Numbers: CT1004
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: March 2013

Keywords provided by Boston Scientific Corporation:
atrial fibrillation
stroke
TIA
trans ischemic attack
warfarin
Coumadin

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants