Phase 3
N=407
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Atrial Fibrillation · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01182441 ↗Enrolled (actual)
407
Serious AEs
31.9%
Results posted
Jul 2018
Primary outcome: Primary: Primary Safety Endpoint (Device Group Only) — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- WATCHMAN Device (Device); Warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jan 2013
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 | — |
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.
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). 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.