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NCT Number: NCT01182441

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mercy Gilbert Medical Center, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WATCHMAN Device

Device

WATCHMAN Left Atrial Appendage Closure Technology

Warfarin

Drug

Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Other names: Coumadin

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: PREVAIL

Important dates

Study start
2010
Primary completion
2013
Study completion
2017
First posted
Aug 16, 2010
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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