Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR)

San Carlos Clinical Hospital

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: Pulmonary vein cryoablation; Device: Pulmonary vein radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00969735

COR-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Cryoablation

Active Comparator group

Description:

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

Treatment:

Device: Pulmonary vein cryoablation

Radiofrequency ablation

Active Comparator group

Description:

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

Treatment:

Device: Pulmonary vein radiofrequency ablation