Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
Phase 3
Completed
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Procedure: cryoballoon ablationProcedure: Radiofrequency ablation
- Registration Number
- NCT01611701
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Previous failed first radiofrequency ablation procedure (only circumferential PV isolation without linear lesions) in patients referred for second catheter ablation of AF
- > 3 months after first PVI
Exclusion Criteria
- Congestive heart failure
- Ejection fraction <35%
- Left atrial diameter >60 mm
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryoballoon group cryoballoon ablation - RF group Radiofrequency ablation -
- Primary Outcome Measures
Name Time Method Recurrence of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a second ablation procedure 1 year
- Secondary Outcome Measures
Name Time Method Percentage of complication after procedure between two groups 1 year
Trial Locations
- Locations (2)
State Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
The Valley Health System and Columbia University College of Physicians & Surgeons
🇺🇸New York, New York, United States