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

NCT00816192 | Terminated

• 1 other identifier: CHUBX 2008/27
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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).

Conditions

Atrial Fibrillation

Keywords

FA; Atrial fibrillation; Catheter; Ablation; RF

Outcome Measures

Primary Outcomes (1)

• RF duration (in minutes) to succeed in PVs isolation

  Along intervention

Secondary Outcomes (2)

• The absence of pAF

  at 3 and 6 months off AAD

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

  During 6 months

Study Arms (2)

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

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

Interventions

Long-term electrical isolation of pulmonary veins 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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

University Hospital

Bordeaux, 33064, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel HAÏSSAGUERRE, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: December 31, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

FR (2)