Clinical trial NCT00816192: Comparison of Externally Versus Internally Cooled Tip Catheter Ablation in Paroxysmal Atrial Fibrillation
Official title: Comparison of Externally Versus Internally Cooled Tip Catheter in Achieving Long-term Electrical Isolation of Pulmonary Veins in Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: FA
Atrial fibrillation
Catheter
Ablation
RF
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2008-12-31
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility 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

Primary outcomes:
measure: RF duration (in minutes) to succeed in PVs isolation
timeFrame: Along intervention
Secondary outcomes:
measure: The absence of pAF
timeFrame: at 3 and 6 months off AAD
measure: The determination of serious adverse events (Complications resulting from vascular access will not be included in this category).
timeFrame: During 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: University Hospital, Bordeaux
name: Michel HAÏSSAGUERRE, Pr
role: PRINCIPAL_INVESTIGATOR
References: