Left Atrial Appendage (LAA) Occluders After Catheter Ablation of Atrial Fibrillation

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Treatments: Warfarin

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)

• 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%