Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(The production of the device used in this study has been suspended.)
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00816192
First received: December 30, 2008
Last updated: July 26, 2012
Last verified: July 2012
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:


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 ]

Enrollment: 86
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Experimental: 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
University Hospital
Bordeaux, France, 33064
Clinique Pasteur
Toulouse, France, 31076
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
ClinicalTrials.gov Identifier: NCT00816192     History of Changes
Other Study ID Numbers: CHUBX 2008/27
Study First Received: December 30, 2008
Last Updated: July 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
FA
Atrial fibrillation
Catheter
Ablation
RF

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014