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Contact Force Sensing and Pulmonary Vein Isolation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by JP Albenque, Clinique Pasteur.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: June 28, 2012
Last Update Posted: June 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JP Albenque, Clinique Pasteur

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.

Paroxysmal Atrial Fibrillation Catheter Ablation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by JP Albenque, Clinique Pasteur:

Primary Outcome Measures:
  • Proportion of PVI after exclusive anatomic approach [ Time Frame: Day 0 ]
  • Proportion of patients free of AF after 12-month FU [ Time Frame: One year ]

Secondary Outcome Measures:
  • Total time of fluoroscopy and radiation exposure [ Time Frame: Day 0 ]
  • Total time of RF application required for completed PVI [ Time Frame: Day 0 ]
  • Proportion of pericardial effusion at echocardiography [ Time Frame: Day 1 ]

Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630031

Clinique Pasteur
Toulouse, France, 31076
Sponsors and Collaborators
Clinique Pasteur
Principal Investigator: Jean-Paul Albenque, M.D. Clinique Pasteur
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JP Albenque, M.D., Clinique Pasteur
ClinicalTrials.gov Identifier: NCT01630031     History of Changes
Other Study ID Numbers: 1
First Submitted: June 23, 2012
First Posted: June 28, 2012
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by JP Albenque, Clinique Pasteur:
atrial fibrillation
contact force
catheter ablation
pulmonary vein isolation

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