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Contact Force Sensing and Pulmonary Vein Isolation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01630031
Enrollment
60
Registered
2012-06-28
Start date
2010-11-30
Completion date
2012-11-30
Last updated
2012-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Ablation, Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillation, paroxysmal, contact force, radiofrequency, catheter ablation, pulmonary vein isolation, recurrence, follow-up

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.

Interventions

None listed

Sponsors

Clinique Pasteur
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Proportion of PVI after exclusive anatomic approachDay 0
Proportion of patients free of AF after 12-month FUOne year

Secondary

MeasureTime frame
Total time of fluoroscopy and radiation exposureDay 0
Total time of RF application required for completed PVIDay 0
Proportion of pericardial effusion at echocardiographyDay 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026