Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Pulmonary vein cryoablation; Device: Pulmonary vein radiofrequency ablation

• Registration Number: NCT00969735
• Lead Sponsor: Hospital San Carlos, Madrid

Brief Summary

This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.

Detailed Description

Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.

An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.

This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Symptomatic recurrent paroxysmal AF (>2 episodes in the last 6 months), and
• Refractory to one or more class I or III antiarrhythmic drugs, and
• PV anatomy consisting of 4 single PV, with the long diameter of the right superior PV ostium ≤ 20 mm.

Exclusion Criteria

• Age: < 18 or > 75 year-old
• Prior AF ablation
• Pregnancy
• Concomitant acute illness
• Hyperthyroidism
• Moderate to severe valvular heart disease
• Prior cardiac surgery
• Left atrium > 50 mm (anteroposterior diameter, parasternal long-axis view)
• Intracardiac thrombus
• Contraindications for anticoagulant therapy
• Inability to be followed in our center for at least 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation	Pulmonary vein cryoablation	Deflectable over-the-wire cryoablation balloon catheter (Arctic Front®, Cryocath Technologies)
Radiofrequency ablation	Pulmonary vein radiofrequency ablation	Open irrigation ablation catheter (Navistar® Thermo-cool®, Biosense Webster Inc).

Primary Outcome Measures

Name	Time	Method
Proportion of patients without AF recurrences longer than 2 minutes	At the 12th month from ablation (using a blanking period of 3 months following ablation)

Secondary Outcome Measures

Name	Time	Method
Time to first AF recurrence longer than 2 minutes	Within the first 12 months from ablation (using a blanking period of 3 months following ablation, and without the use of any blanking period)
Cumulative burden of AF (number of AF episodes longer than 2 minutes)	At the 12th month from ablation (using a blanking period of 3 months following ablation)
Cumulative burden of AF (percentage of time in AF)	At the 12th month from ablation (using a blanking period of 3 months following ablation)
Proportion of patients with episodes of regular atrial tachycardia or atrial flutter requiring treatment with drugs, electrical cardioversion or ablation.	Within the first 12 months from ablation
Quality of Life and symptom status	At the 12th month from ablation
Proportion of patients with procedure-related complications	Within the first 12 months from ablation
Procedure time (minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter)	At the end of the ablation procedure
Ablation time (minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery).	At the end of the ablation procedure
Fluoroscopy time (minutes of fluoroscopy used during the entire ablation procedure)	At the end of the ablation procedure
Proportion of pulmonary veins remaining isolated	At the end of the ablation procedure

Trial Locations

Locations (1)

Unidad de Arritmias, Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain