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

NCT ID: NCT00816192

Last Updated: 2012-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-03-31

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.

Conditions

Atrial Fibrillation

Keywords

FA; Atrial fibrillation; Catheter; Ablation; RF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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.

Group Type: ACTIVE_COMPARATOR

Long-term electrical isolation of pulmonary veins

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Long-term electrical isolation of pulmonary veins

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel HAÏSSAGUERRE, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

University Hospital

Bordeaux, , France

Clinique Pasteur

Toulouse, , France

Countries

France

Other Identifiers

CHUBX 2008/27

Identifier Type: -

Identifier Source: org_study_id