Contact Force Sensing and Pulmonary Vein Isolation

Study Overview
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Brief Summary
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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.

Official Title
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Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation, Catheter Ablation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc. | |
| CF group<br>Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of PVI after exclusive anatomic approach |  | Day 0 | 
| Proportion of patients free of AF after 12-month FU |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, paroxysmal, contact force, radiofrequency, catheter ablation, pulmonary vein isolation, recurrence, follow-up