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

Completed · Phase 3

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01611701

Run by

Meshalkin Research Institute of Pathology of Circulation

People needed

80

Starts

2009-10-01

Expected to finish

2012-02-01

Last updated by the study team

2012-06-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Congestive heart failure
• Ejection fraction <35%
• Left atrial diameter >60 mm

Where it is running

• The Valley Health System and Columbia University College of Physicians & Surgeons — New York, New York, United States
• State Research Institute of Circulation Pathology — Novosibirsk, Russia

Full record on ClinicalTrials.gov

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