Comparison of Externally Versus Internally Cooled Tip Catheter Ablation in Paroxysmal Atrial Fibrillation - Full Text View

Sponsor:	University Hospital, Bordeaux
Collaborator:	Boston Scientific Corporation
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00816192

Purpose

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).

Condition	Intervention
Atrial Fibrillation	Procedure: Long-term electrical isolation of pulmonary veins

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Externally Versus Internally Cooled Tip Catheter in Achieving Long-Term Electrical Isolation of Pulmonary Veins in Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

RF duration (in minutes) to succeed in PVs isolation [ Time Frame: Along intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The absence of pAF [ Time Frame: at 3 and 6 months off AAD ] [ Designated as safety issue: No ]
The determination of serious adverse events (Complications resulting from vascular access will not be included in this category). [ Time Frame: During 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator The externally irrigated-tip catheter is an "open system" in which saline is continuously infused and empties into the blood pool. For the externally irrigated-tip catheter, RF energy delivery settings were: power ≤ 35 watts and temperature ≤ 43°C with a variable flow-rate to obtain a temperature around 40°C.	Procedure: Long-term electrical isolation of pulmonary veins All AAD except amiodarone will be stopped five half-lives before the procedure. Our ablation protocol will require 3 catheters. A quadripolar stearable mapping catheter was inserted into the coronary sinus, a decapolar circular mapping catheter was placed at the antrum of the PV after transeptal puncture to help for electrical disconnection of all four PV with the randomized ablation catheter. After transseptal access, an intravenous bolus of heparin was administered and repeated 3 to 4 hours later. Atrial burst will then be used to induce AF. With the ablation catheter positioned proximal to Lasso catheter on the atrial aspect of PV ostium, isolation will be performed.
2: Experimental For the internally irrigated tip catheter (reference catheter), radiofrequency (RF) energy delivery settings will be: power ≤ 35 watts, temperature ≤ 47◦C and a fixed flow rate of 0.6 ml/s. The advantage of the Chili thermo-cooled tip system is that no saline solution leaves the catheter system and flows into the patient.	Procedure: Long-term electrical isolation of pulmonary veins All AAD except amiodarone will be stopped five half-lives before the procedure. Our ablation protocol will require 3 catheters. A quadripolar stearable mapping catheter was inserted into the coronary sinus, a decapolar circular mapping catheter was placed at the antrum of the PV after transeptal puncture to help for electrical disconnection of all four PV with the randomized ablation catheter. After transseptal access, an intravenous bolus of heparin was administered and repeated 3 to 4 hours later. Atrial burst will then be used to induce AF. With the ablation catheter positioned proximal to Lasso catheter on the atrial aspect of PV ostium, isolation will be performed.

Arms

Assigned Interventions

1: Active Comparator

The externally irrigated-tip catheter is an "open system" in which saline is continuously infused and empties into the blood pool. For the externally irrigated-tip catheter, RF energy delivery settings were: power ≤ 35 watts and temperature ≤ 43°C with a variable flow-rate to obtain a temperature around 40°C.

Procedure: Long-term electrical isolation of pulmonary veins

All AAD except amiodarone will be stopped five half-lives before the procedure. Our ablation protocol will require 3 catheters. A quadripolar stearable mapping catheter was inserted into the coronary sinus, a decapolar circular mapping catheter was placed at the antrum of the PV after transeptal puncture to help for electrical disconnection of all four PV with the randomized ablation catheter. After transseptal access, an intravenous bolus of heparin was administered and repeated 3 to 4 hours later. Atrial burst will then be used to induce AF. With the ablation catheter positioned proximal to Lasso catheter on the atrial aspect of PV ostium, isolation will be performed.

2: Experimental

For the internally irrigated tip catheter (reference catheter), radiofrequency (RF) energy delivery settings will be: power ≤ 35 watts, temperature ≤ 47◦C and a fixed flow rate of 0.6 ml/s.

The advantage of the Chili thermo-cooled tip system is that no saline solution leaves the catheter system and flows into the patient.

Procedure: Long-term electrical isolation of pulmonary veins

All AAD except amiodarone will be stopped five half-lives before the procedure. Our ablation protocol will require 3 catheters. A quadripolar stearable mapping catheter was inserted into the coronary sinus, a decapolar circular mapping catheter was placed at the antrum of the PV after transeptal puncture to help for electrical disconnection of all four PV with the randomized ablation catheter. After transseptal access, an intravenous bolus of heparin was administered and repeated 3 to 4 hours later. Atrial burst will then be used to induce AF. With the ablation catheter positioned proximal to Lasso catheter on the atrial aspect of PV ostium, isolation will be performed.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816192

Contacts

Contact: Michel HAÏSSAGUERRE, Pr	33-(0)5 57 65 64 71	michel.haissaguerre@chu-bordeaux.fr
Contact: Valérie AURILLAC-LAVIGNOLE, CRA	33-(0)5 57 65 65 65	valerie.aurillac@chu-bordeaux.fr

Locations

France
University Hospital	Recruiting
Bordeaux, France, 33064
Contact: Frédéric SACHER, Md 33-(0)5 57 65 64 71 frederic.sacher@chu-bordeaux.fr
Contact: Valérie AURILALC-LAVIGNOLE, CRA 33-(0)5 57 65 65 65 valerie.aurilalc@chu-bordeaux.fr
Sub-Investigator: Pierre JAÏS, Md
Sub-Investigator: Mélèze HOCINI, Md
Principal Investigator: Michel HAÏSSAGUERRE, Pr
Sub-Investigator: Frédéric SACHER, Md
Clinique Pasteur	Recruiting
Toulouse, France, 31076
Contact: Jean-Paul ALBENQUE, Md 33-(0)5 62 21 31 31 j.albenque@clinique-pasteur.com
Contact: serge BOVEDA, Md 33-(0)5 62 21 31 31 s.boveda@clinique-pasteur.com
Sub-Investigator: Serge Boveda, Md
Principal Investigator: Jean-Paul ALBENQUE, Md

Sponsors and Collaborators

University Hospital, Bordeaux

Boston Scientific Corporation

Investigators

Principal Investigator:

Michel HAÏSSAGUERRE, Pr

University Hospital, Bordeaux

More Information

No publications provided

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	CHUBX 2008/27
Study First Received:	December 30, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00816192 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

FA
Atrial fibrillation
Catheter
Ablation
RF

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010