Clinical trial NCT01630031: Contact Force Sensing and Pulmonary Vein Isolation
Official title: Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paroxysmal Atrial Fibrillation
Catheter Ablation
Keywords: atrial fibrillation
paroxysmal
contact force
radiofrequency
catheter ablation
pulmonary vein isolation
recurrence
follow-up
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population included patients with paroxysmal atrial fibrillation who undergo a first catheter ablation procedure (pulmonary vein isolation).

Brief summary: Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome.

Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for PVI.

Methods - Prospective observational non-randomized monocentric study. Patients with paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. All procedures is performed by the same experienced operator, not blinded to the catheter used. Except for CF information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled in a specific follow-up plan.

Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of patients free of AF after 12-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Symptomatic paroxysmal atrial fibrillation despite at least failure of one anti-arrhythmic drug
* Age 18-75 yrs
* First catheter ablation

Exclusion Criteria:

* Left ventricle ejection fraction at echocardiography \<50%
* History of heart surgery

Primary outcomes:
measure: Proportion of PVI after exclusive anatomic approach
timeFrame: Day 0
measure: Proportion of patients free of AF after 12-month FU
timeFrame: One year
Secondary outcomes:
measure: Total time of fluoroscopy and radiation exposure
timeFrame: Day 0
measure: Total time of RF application required for completed PVI
timeFrame: Day 0
measure: Proportion of pericardial effusion at echocardiography
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Clinique Pasteur
name: Jean-Paul Albenque, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marijon E, Fazaa S, Narayanan K, Guy-Moyat B, Bouzeman A, Providencia R, Treguer F, Combes N, Bortone A, Boveda S, Combes S, Albenque JP. Real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results. J Cardiovasc Electrophysiol. 2014 Feb;25(2):130-7. doi: 10.1111/jce.12303. Epub 2013 Nov 6.