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Atrial FibrillationPhase 3PREVAILNCT01182441

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

A Phase 3 study testing WATCHMAN Device and Warfarin in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Stroke
What is being tested?
WATCHMAN Device and Warfarin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
41 sitesUnited States
Study dates
Nov 2010to Nov 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30308

  • Zasa Clinical Research

    Atlantis, Florida, 33462

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Fletcher Allen

    Burlington, Vermont, 05401

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor Research Institute

    Dallas, Texas, 75226

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • North Shore University

    Evanston, Illinois, 60201

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Methodist Hospital

    Houston, Texas, 77030

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Foundation for Cardiovascular Medicine

    La Jolla, California, 92037

  • Scripps Green

    La Jolla, California, 92037

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Bryan LGH

    Lincoln, Nebraska, 68506

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • St. Luke's Hospital

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • St. Thomas Research Institute

    Nashville, Tennessee, 37203

  • New York University Medical Center

    New York, New York, 10016

  • Mt. Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Orange County Heart

    Orange, California, 92868

  • Florida Hospital

    Orlando, Florida, 32803

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • William Beaumont

    Royal Oak, Michigan, 48073

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107

  • St. John's Hospital / Pacific Heart

    Santa Monica, California, 90404

  • Arizona Heart Rhythm Research Center

    Scottsdale, Arizona, 85251

  • Swedish Medical Center

    Seattle, Washington, 98104

  • St. John's Mercy

    St Louis, Missouri, 63141

  • Cardiology Associates of N. Mississippi

    Tupelo, Mississippi, 38801

  • Moffitt Heart & Vascular

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

About this study

Official title: Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) 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.

Being tested
WATCHMAN Device, Warfarin
Keywords
atrial fibrillation, stroke, TIA, trans ischemic attack, warfarin, Coumadin
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATCHMAN DeviceDevice

    WATCHMAN Left Atrial Appendage Closure Technology

  • WarfarinDrug

    Also called Coumadin

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

Study groups in NCT01182441
Study groupRoleWhat they receive
WATCHMANExperimentalSubjects assigned to receive the WATCHMAN device.
Receives: Device: WATCHMAN Device
WarfarinActive comparatorSubjects assigned to warfarin therapy.
Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint (Device Group Only)

    7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.

    Measured: 7-Day

  2. Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)

    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.

    Measured: 18 month rate

  3. Composite of Ischemic Stroke or Systemic Embolism

    Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization

    Measured: Day 8 to 18-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2013
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01182441
Sponsor's protocol ID
CT1004
Acronym
PREVAIL
Status last verified
Mar 2017
First submitted
12 Aug 2010
Last updated
26 Jul 2018
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Dukkipati SR, Holmes DR Jr, Doshi SK, Kar S, Singh SM, Gibson D, Price MJ, Natale A, Mansour M, Sievert H, Houle VM, Allocco DJ, Reddy VY. Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure. J Am Coll Cardiol. 2022 Aug 2;80(5):469-483. doi: 10.1016/j.jacc.2022.04.062.

    PubMed 35902169

  • Friedman DJ, Du C, Wang Y, Agarwal V, Varosy PD, Masoudi FA, Holmes DR, Reddy VY, Price MJ, Curtis JP, Freeman JV. Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials. JACC Cardiovasc Interv. 2022 May 9;15(9):950-961. doi: 10.1016/j.jcin.2022.02.029.

    PubMed 35512918

  • Brouwer TF, Whang W, Kuroki K, Halperin JL, Reddy VY. Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies. J Am Heart Assoc. 2019 Dec 3;8(23):e013525. doi: 10.1161/JAHA.119.013525. Epub 2019 Nov 22.

    PubMed 31752643

  • Price MJ, Reddy VY, Valderrabano 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.

    PubMed 26627989

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing WATCHMAN Device and Warfarin in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint (Device Group Only) (time frame: 7-Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01182441, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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