Comparison of Externally Versus Internally Cooled Tip Catheter Ablation in Paroxysmal Atrial Fibrillation

Condition(s) targeted: Atrial Fibrillation

Intervention: Long-term electrical isolation of pulmonary veins (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Bordeaux

Official(s) and/or principal investigator(s):
Michel HAÏSSAGUERRE, Pr, Principal Investigator, Affiliation: University Hospital, Bordeaux

Overall contact:
Michel HAÏSSAGUERRE, Pr, Phone: 33-(0)5 57 65 64 71, Email: michel.haissaguerre@chu-bordeaux.fr

There is no study comparing safety/efficacy of externally vs internally cooled tip catheters in patients undergoing ablation for paroxysmal atrial fibrillation (pAF).

The primary objective is to compare safety and efficacy of externally irrigated-tip catheter versus internally irrigated-tip catheter in achieving long term electrical isolation (EI) of pulmonary veins (PV) in paroxysmalatrial fibrillation (pAF).

Official title: Comparison of Externally Versus Internally Cooled Tip Catheter in Achieving Long-Term Electrical Isolation of Pulmonary Veins in Paroxysmal Atrial Fibrillation

Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: RF duration (in minutes) to succeed in PVs isolation

Secondary outcome:

The absence of pAF

The determination of serious adverse events (Complications resulting from vascular access will not be included in this category).

Detailed description: Atrial fibrillation is the most common of all sustained cardiac arrhythmias, with the prevalence increasing with age to up to 5 percent in persons more than 65 years of age, to 10 percent in persons more than 80 years of age and it is a major cause of stroke.

Since its introduction into clinical practice, catheter ablation (CA) aimed at cure of atrial fibrillation (AF) has become increasingly prevalent. Different techniques have been proposed and are currently under investigation in various electrophysiology (EP) laboratories, with increasing knowledge of the pathophysiology of human AF and critical assessment of clinical outcome after the curative procedure. The favorable results reported in different studies have fueled enthusiasm for CA of AF, with the number of ablation procedures increasing from 1994 to the present time. However, these technologies have varied catheter designs, ranging from different forms of irrigation (external or internal irrigation). The increase of the rate of success of the AF by ablation with the development of new catheters has permitted a considerable reduction of the medical treatment and the disappearance of grave complications. The procedure will be " standard " with isolation of pulmonary veins and block through the cavo-tricuspid isthmus obtained.

Following completion of the procedure, patients will have anti vitamin K drug therapy for 3 months and antiarrhythmic drug for 1 month in case of early atrial arrhythmia recurrence. Two-dimensional echocardiogram will be performed systematically prior to discharge. All 3 months, long-term follow-up consisted from the date of the ablation procedure with consultation, stress test, holter-ECG (24 h) and echocardiography. At 3 months a repeat EP procedure will be performed in patients with AF recurrence to assess whether or not lines are still blocked. If not, RF will be delivered to block them again and cure AF.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults (≥18 years old)

- Drug refractory paroxysmal AF with episods lasting <24hours

- Follow-up possible at one of the 2 institutions performing the study

- Oral agreement of the patient after reading the document of information

Exclusion Criteria:

- Pregnancy

- Psychiatric troubles not stabilized

- Contraindication to undergo AF ablation

- Previous attempt at AF ablation

- Cardioversion for AF

- No oral agreement of the patient for the study

Michel HAÏSSAGUERRE, Pr, Phone: 33-(0)5 57 65 64 71, Email: michel.haissaguerre@chu-bordeaux.fr

University Hospital, Bordeaux 33064, France; Recruiting
Frédéric SACHER, Md, Phone: 33-(0)5 57 65 64 71, Email: frederic.sacher@chu-bordeaux.fr
Valérie AURILALC-LAVIGNOLE, CRA, Phone: 33-(0)5 57 65 65 65, Email: valerie.aurilalc@chu-bordeaux.fr
Pierre JAÏS, Md, Sub-Investigator
Mélèze HOCINI, Md, Sub-Investigator
Michel HAÏSSAGUERRE, Pr, Principal Investigator
Frédéric SACHER, Md, Sub-Investigator

Clinique Pasteur, Toulouse 31076, France; Recruiting
Jean-Paul ALBENQUE, Md, Phone: 33-(0)5 62 21 31 31, Email: j.albenque@clinique-pasteur.com
serge BOVEDA, Md, Phone: 33-(0)5 62 21 31 31, Email: s.boveda@clinique-pasteur.com
Serge Boveda, Md, Sub-Investigator
Jean-Paul ALBENQUE, Md, Principal Investigator

Starting date: December 2008
Ending date: December 2010
Last updated: December 30, 2008