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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Procedure: RFA ablation; Drug: Warfarin; Device: LAA occluder

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01695824

WA-PR-AF

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

LAA occluder

Active Comparator group

Treatment:

Device: LAA occluder

Procedure: RFA ablation

Drug: Warfarin

Warfarin

Active Comparator group

Treatment:

Procedure: RFA ablation

Drug: Warfarin