Clinical trial NCT00969735: Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation
Official title: Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Catheter ablation
Cryoenergy
Implantable loop recorder
Pulmonary vein
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Spanish Society of Cardiology
First posted: 2009-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of patients without AF recurrences longer than 2 minutes
timeFrame: At the 12th month from ablation (using a blanking period of 3 months following ablation)
Secondary outcomes:
measure: Time to first AF recurrence longer than 2 minutes
timeFrame: Within the first 12 months from ablation (using a blanking period of 3 months following ablation, and without the use of any blanking period)
measure: Cumulative burden of AF (number of AF episodes longer than 2 minutes)
timeFrame: At the 12th month from ablation (using a blanking period of 3 months following ablation)
measure: Cumulative burden of AF (percentage of time in AF)
timeFrame: At the 12th month from ablation (using a blanking period of 3 months following ablation)
measure: Proportion of patients with episodes of regular atrial tachycardia or atrial flutter requiring treatment with drugs, electrical cardioversion or ablation.
timeFrame: Within the first 12 months from ablation
measure: Quality of Life and symptom status
timeFrame: At the 12th month from ablation
measure: Proportion of patients with procedure-related complications
timeFrame: Within the first 12 months from ablation
measure: Procedure time (minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter)
timeFrame: At the end of the ablation procedure
measure: Ablation time (minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery).
timeFrame: At the end of the ablation procedure
measure: Fluoroscopy time (minutes of fluoroscopy used during the entire ablation procedure)
timeFrame: At the end of the ablation procedure
measure: Proportion of pulmonary veins remaining isolated
timeFrame: At the end of the ablation procedure
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Unidad de Arritmias, Hospital Clínico San Carlos
Study officials:
affiliation: Unidad de Arritmias, Hospital Clínico San Carlos, Madrid, Spain
name: Nicasio Pérez Castellano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: