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Contact Force Sensing and Pulmonary Vein Isolation

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ClinicalTrials.gov Identifier: NCT01630031
Recruitment Status : Unknown
Verified June 2012 by JP Albenque, Clinique Pasteur.
Recruitment status was:  Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
JP Albenque, Clinique Pasteur

Study Description
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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.


Condition or disease
Paroxysmal Atrial Fibrillation Catheter Ablation

Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
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
Study Start Date : November 2010
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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).
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
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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


Locations
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France
Clinique Pasteur
Toulouse, France, 31076
Sponsors and Collaborators
Clinique Pasteur
Investigators
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Principal Investigator: Jean-Paul Albenque, M.D. Clinique Pasteur
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: JP Albenque, M.D., Clinique Pasteur
ClinicalTrials.gov Identifier: NCT01630031    
Other Study ID Numbers: 1
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by JP Albenque, Clinique Pasteur:
atrial fibrillation
paroxysmal
contact force
radiofrequency
 catheter ablation
pulmonary vein isolation
recurrence
follow-up
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes