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Clinical Trial Summary

This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ (TactiCath SE)) for the treatment of AF.


Clinical Trial Description

This post-approval study is a prospective, non-randomized, single arm, multicenter, observational study to evaluate the continued safety and effectiveness of AF RF technologies, including the TactiCath SE. The primary effectiveness endpoint will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 12 months of follow-up (includes a 90-day blanking period). Secondary effectiveness endpoints will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 24 and 36 months of follow-up (includes a 90-day blanking period). The acute primary safety endpoint will be the rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure utilizing the study catheter. The secondary, long-term safety endpoint will be the rate of device and/or procedure-related SAEs from the index ablation procedure. An independent Clinical Event Committee (CEC) will review all Adverse Device Effects (ADEs) and SAEs and will adjudicate causality relative to the primary safety endpoints. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05434650
Study type Observational
Source Abbott Medical Devices
Contact Todd Stirman
Phone 972-526-9625
Email todd.stirman@abbott.com
Status Recruiting
Phase
Start date October 21, 2022
Completion date November 30, 2026

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