Contact Force Sensing and Pulmonary Vein Isolation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Clinique Pasteur.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
JP Albenque, Clinique Pasteur
ClinicalTrials.gov Identifier:
NCT01630031
First received: June 23, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition
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 Clinique Pasteur:

Primary Outcome Measures:
  • Proportion of PVI after exclusive anatomic approach [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Proportion of patients free of AF after 12-month FU [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total time of fluoroscopy and radiation exposure [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Total time of RF application required for completed PVI [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Proportion of pericardial effusion at echocardiography [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

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)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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).

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
  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: NCT01630031

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

No publications provided

Responsible Party: JP Albenque, M.D., Clinique Pasteur
ClinicalTrials.gov Identifier: NCT01630031     History of Changes
Other Study ID Numbers: 1
Study First Received: June 23, 2012
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Clinique Pasteur:
atrial fibrillation
paroxysmal
contact force
radiofrequency
catheter ablation
pulmonary vein isolation
recurrence
follow-up

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

ClinicalTrials.gov processed this record on October 21, 2014