Left Atrial Appendage (LAA) Occluders After Catheter Ablation of Atrial Fibrillation
Phase 2
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT01695824
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LAA occluder LAA occluder - LAA occluder RFA ablation - Warfarin RFA ablation - LAA occluder Warfarin - Warfarin Warfarin -
- Primary Outcome Measures
Name Time Method Systemic embolism 12 months Cardiovascular death 12 months All stroke 12 months
- Secondary Outcome Measures
Name Time Method 30 day major adverse event (MAE) 30 days Left atrial appendage (LAA) coverage 45 days Technical success 45 days Procedure success 45 days
Trial Locations
- Locations (1)
State Research Institute of CIrculation Pathology
🇷🇺Novosibirsk, Russian Federation