Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation

NCT00969735 | Completed Phase 4

• 1 other identifier: COR-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Catheter ablation; Cryoenergy; Implantable loop recorder; Pulmonary vein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Cryoablation

ACTIVE COMPARATOR

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

Device: Pulmonary vein cryoablation

Radiofrequency ablation

ACTIVE COMPARATOR

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

Device: Pulmonary vein radiofrequency ablation

Interventions

Pulmonary vein cryoablation 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.

Also known as: Cryoenergy balloon catheter ablation

Cryoablation

Pulmonary vein radiofrequency ablation 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.

Also known as: Pulmonary vein isolation

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Spanish Society of Cardiology: collaborator

Study Sites (1)

Unidad de Arritmias, Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicasio Pérez Castellano, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: September 1, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

ES (1)