Study Results
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Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2010-11-30
2012-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control group
Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.
No interventions assigned to this group
CF group
Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 18-75 yrs
* First catheter ablation
Exclusion Criteria
* History of heart surgery
18 Years
75 Years
ALL
Yes
Sponsors
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Clinique Pasteur
OTHER
Responsible Party
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JP Albenque
M.D.
Principal Investigators
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Jean-Paul Albenque, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur
Locations
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Clinique Pasteur
Toulouse, , France
Countries
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References
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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.
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id
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