THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
Condition(s) studied
Study 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.
Eligibility
Primary outcome measure(s)
- Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. — 91-365 days
Atrial tachyarrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03963349 on ClinicalTrials.gov ↗ ← All trials in China