Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR Trial)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Proportion of patients without AF recurrences longer than 2 minutes
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Nicasio Perez Castellano
MD, PhD
Hospital San Carlos, Madrid
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
Outcomes
Primary Outcomes
Proportion of patients without AF recurrences longer than 2 minutes
Time Frame: At the 12th month from ablation (using a blanking period of 3 months following ablation)
Secondary Outcomes
- Proportion of pulmonary veins remaining isolated(At the end of the ablation procedure)
- 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)