Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 3

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: cryoballoon ablation; Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01611701

RFA-655-CA

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Cryoballoon group

Active Comparator group

Treatment:

Procedure: cryoballoon ablation

RF group

Active Comparator group

Treatment:

Procedure: Radiofrequency ablation