NCT05434650

Abbott Atrial Fibrillation Post Approval Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of AF.

Detailed 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.

Conditions

• Atrial Arrhythmia
• Atrium; Fibrillation
• Atrial Tachycardia

Interventions

Type	Name	Description
DEVICE	electrophysiology study and ablation with an Abbott Ablation Catheter	During the cardiac ablation procedure, an ablation catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) will deliver radiofrequency energy (a type of heat) to one or more areas in the upper left chamber of the heart that is causing the irregular heartbeat. The tip of the catheter will transmit energy to one or more small spots of heart tissue. This energy creates a small scar on the heart. This scar will block the electrical pathway that is causing the rapid heartbeat

Timeline

• Start date: 2022-10-21
• Primary completion: 2024-10-22
• Completion: 2026-11-30
• First posted: 2022-06-28
• Last updated: 2025-11-19

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study