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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Cryoballoon Ablation of Pulmonary Veins After Failed Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611701
• Other study ID #: RFA-655-CA
• Status: Completed
• Phase: Phase 3
• First received: May 25, 2012
• Last updated: June 1, 2012
• Start date: October 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• cryoballoon ablation
In Cryo group, 28mm balloon was introduced into the PV ostium with the best possible occlusion of the PV. Every step was controlled by fluoroscopy. Cryoenergy was applied for maximal 6 minutes per application for 2 times, resulting in a circumferential ablation lesion. Before the right superior vein was treated, a quadripolar catheter was placed in the superior vena cava to continuously stimulate the right phrenic nerve during cryoapplication. The application was stopped immediately in the case of diminished diaphragm movements.
• Radiofrequency ablation
n RF group, reisolation of the PV was performed by identifying the breakthrough site. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
United States	The Valley Health System and Columbia University College of Physicians & Surgeons	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a second ablation procedure		1 year	Yes
Secondary	Percentage of complication after procedure between two groups		1 year	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site