Contact Force Sensing and Pulmonary Vein Isolation

NCT01630031 | Unknown

• 1 other identifier: 1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation; Catheter Ablation

Keywords

atrial fibrillation; paroxysmal; contact force; radiofrequency; catheter ablation; pulmonary vein isolation; recurrence; follow-up

Outcome Measures

Primary Outcomes (2)

• Proportion of PVI after exclusive anatomic approach

  Day 0

• Proportion of patients free of AF after 12-month FU

  One year

Secondary Outcomes (3)

• Total time of fluoroscopy and radiation exposure

  Day 0

• Total time of RF application required for completed PVI

  Day 0

• Proportion of pericardial effusion at echocardiography

  Day 1

Study Arms (2)

Control group

Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.

CF group

Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (1)

Clinique Pasteur

Toulouse, 31076, France

Location

Related Publications (1)

• 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.

  PMID: 24433324 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Paul Albenque, M.D.

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 23, 2012
• First Posted: June 28, 2012
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

FR (1)