Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Public ClinicalTrials.gov record NCT01182441. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01182441
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 407 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2010 (Actual)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Nov 2017 (Actual)
- Last update posted
- Jul 26, 2018
2010 – 2017
United States locations
- U.S. sites
- 41
- U.S. states
- 24
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | — |
| Arizona Heart Rhythm Research Center | Scottsdale | Arizona | 85251 | — |
| Foundation for Cardiovascular Medicine | La Jolla | California | 92037 | — |
| Scripps Green | La Jolla | California | 92037 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Orange County Heart | Orange | California | 92868 | — |
| St. John's Hospital / Pacific Heart | Santa Monica | California | 90404 | — |
| Zasa Clinical Research | Atlantis | Florida | 33462 | — |
| Baptist Hospital of Miami | Miami | Florida | 33176 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| North Shore University | Evanston | Illinois | 60201 | — |
| Iowa Heart Center | Des Moines | Iowa | 50314 | — |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| William Beaumont | Royal Oak | Michigan | 48073 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Cardiology Associates of N. Mississippi | Tupelo | Mississippi | 38801 | — |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | — |
| St. John's Mercy | St Louis | Missouri | 63141 | — |
| Bryan LGH | Lincoln | Nebraska | 68506 | — |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | — |
| 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 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Moffitt Heart & Vascular | Wormleysburg | Pennsylvania | 17043 | — |
| St. Thomas Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | — |
| Baylor Research Institute | Dallas | Texas | 75226 | — |
| Methodist Hospital | Houston | Texas | 77030 | — |
| Intermountain Medical Center | Salt Lake City | Utah | 84107 | — |
| Fletcher Allen | Burlington | Vermont | 05401 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
| St. Luke's Hospital | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01182441, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2018 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01182441 live on ClinicalTrials.gov.