Phase 3
Completed N=407
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Source: ClinicalTrials.gov NCT01182441 ↗Enrolled (actual)
407
Serious AEs
31.9%
Results posted
Jul 2018
Primary outcomePrimary: Primary Safety Endpoint (Device Group Only) — 6 Participants
◆ Published Evidence
Highly cited
130citations · ~33 / year
Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure.
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 LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.
Linked Publications (4)
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Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure.
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Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience.
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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.
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Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint (Device Group Only) |
6 | — |
| PRIMARY Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown) |
0.064; 0.063 | — |
| PRIMARY Composite of Ischemic Stroke or Systemic Embolism |
0.0253; 0.0200 | — |
Eligibility 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 110 bpm
- Participated previously in the PROTECT AF or CAP Registry studies
Key Echo Exclusion Criteria:
- LVEF 2mm
- High risk PFO
- Significant mitral valve stenosis
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
- Cardiac tumor
Data sourced from ClinicalTrials.gov (NCT01182441) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.