Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation

NCT ID: NCT00969735

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-05-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cryoablation

Deflectable over-the-wire cryoablation balloon catheter (Arctic Front®, Cryocath Technologies)

Group Type: ACTIVE_COMPARATOR

Pulmonary vein cryoablation

Intervention Type: DEVICE

A deflectable over-the-wire cryoablation balloon catheter (Arctic Front®) will be inflated and be positioned at each PV antrum. Then, cryoenergy will be delivered for 300 seconds. During cryoablation of the right PVs, the right phrenic nerve integrity will be monitored by the observation of right hemi-diaphragm contractions in response to right phrenic nerve pacing at the superior vena cava. Once the 4 PVs are cryoablated, the Arctic Front® catheter will be replaced by a decapolar PV mapping circular catheter (Lasso®, Biosense Webster, Diamond Bar, California, EEUU) to evaluate PV conduction. A second cryoablation application may be delivered at each PV, if necessary. Crossover to RF ablation to complete PV isolation is discouraged.

Radiofrequency ablation

Open irrigation ablation catheter (Navistar® Thermo-cool®, Biosense Webster Inc).

Group Type: ACTIVE_COMPARATOR

Pulmonary vein radiofrequency ablation

Intervention Type: DEVICE

Ablation approach is ostial electrical isolation of all PVs with simultaneous use of the CARTO® electroanatomic mapping system (Biosense Webster, Tirat-Ha-Carmel, Israel). PV isolation will be performed by delivering RF energy at ostial sites with earliest PV potentials. Flow rate during the RF applications will be set at 15 mL/min (baseline 2 mL/min). Temperature and power limits will be set at 45ºC and 35 W. It will be allowed a 5 W reduction in power limit setting for small PVs (angiographic supero-inferior diameter \> 12 mm), and a 5 W increase in areas located away from the esophagus, and for focal applications at sites resistant to ablation or recurrent gaps. The end-point of ablation will be to achieve bidirectional PV conduction block.

Interventions

Pulmonary vein cryoablation

A deflectable over-the-wire cryoablation balloon catheter (Arctic Front®) will be inflated and be positioned at each PV antrum. Then, cryoenergy will be delivered for 300 seconds. During cryoablation of the right PVs, the right phrenic nerve integrity will be monitored by the observation of right hemi-diaphragm contractions in response to right phrenic nerve pacing at the superior vena cava. Once the 4 PVs are cryoablated, the Arctic Front® catheter will be replaced by a decapolar PV mapping circular catheter (Lasso®, Biosense Webster, Diamond Bar, California, EEUU) to evaluate PV conduction. A second cryoablation application may be delivered at each PV, if necessary. Crossover to RF ablation to complete PV isolation is discouraged.

Intervention Type: DEVICE

Pulmonary vein radiofrequency ablation

Ablation approach is ostial electrical isolation of all PVs with simultaneous use of the CARTO® electroanatomic mapping system (Biosense Webster, Tirat-Ha-Carmel, Israel). PV isolation will be performed by delivering RF energy at ostial sites with earliest PV potentials. Flow rate during the RF applications will be set at 15 mL/min (baseline 2 mL/min). Temperature and power limits will be set at 45ºC and 35 W. It will be allowed a 5 W reduction in power limit setting for small PVs (angiographic supero-inferior diameter \> 12 mm), and a 5 W increase in areas located away from the esophagus, and for focal applications at sites resistant to ablation or recurrent gaps. The end-point of ablation will be to achieve bidirectional PV conduction block.

Intervention Type: DEVICE

Other Intervention Names

Cryoenergy balloon catheter ablation; Pulmonary vein isolation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Cardiology

OTHER

Sponsor Role: collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Nicasio Perez Castellano

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicasio Pérez Castellano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Arritmias, Hospital Clínico San Carlos, Madrid, Spain

Locations

Unidad de Arritmias, Hospital Clínico San Carlos

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

COR-1

Identifier Type: -

Identifier Source: org_study_id