Phase 3
Completed N=800
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Source: ClinicalTrials.gov NCT00129545 ↗Enrolled (actual)
800
Serious AEs
30.3%
Results posted
May 2015
Primary outcomePrimary: Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death — 2.2; 3.7 events per 100 pt yrs
Summary
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death |
2.2; 3.7 | — |
| PRIMARY The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events |
3.5; 3.2 | — |
| SECONDARY Procedure Success |
90.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
- Eligible for long term warfarin
- CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)]
Exclusion Criteria
- Contraindicated for warfarin
- Contraindicated for aspirin or clopidogrel (Plavix)
- Congestive heart failure (CHF) Class 4
- Implanted mechanical valve
- Atrial septal or Patent Foramen Ovale (PFO) device
- Platelets < 100, 000 or hemoglobin < 10
- Left ventricular ejection fraction (LVEF) < 30%
Data sourced from ClinicalTrials.gov (NCT00129545). 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.