NCT03963349

THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.

Detailed description

The purpose of this study is to measure the long term effectiveness，clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up. Subject:Up to 150 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site. Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge) * Numbers of reconnected pulmonary veins (PV), with number and location of any gaps * Procedural efficiency measures（e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter. * AI values * Inter-Tag distances * Adverse events (Complications related to device or procedure) * Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 18-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.

Conditions

• Paroxysmal Atrial Fibrillation

Timeline

• Start date: 2019-06-24
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2019-05-24
• Last updated: 2026-04-13

Locations

1 site across 1 country: China