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
  Purpose

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 Intervention Phase
Atrial Fibrillation
Stroke
Device: WATCHMAN Device
Drug: Warfarin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 475
Study Start Date: November 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01182441     History of Changes
Other Study ID Numbers: CT1004
Study First Received: August 12, 2010
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014