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.
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 Type
OBSERVATIONAL
Enrollment
200
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
Heart Center Research, LLC.
Huntsville, Alabama, United States
Arkansas Cardiology
Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months
AF recurrence is defined as: 1. Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of \> 30 seconds duration following the blanking period 2. Repeat ablation for AF/AFL/AT following the blanking period 3. Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period 4. A new Class I/III AAD or a previously failed Class I/III AAD at a dose greater than the highest historical dose for AF is needed following the blanking period
Time frame: 12 months
Rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure
Device and/or index procedure-related SAEs are defined below: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction (MI) * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Vagal nerve injury/gastroparesis * Pulmonary edema (respiratory insufficiency) * Pulmonary vein stenosis * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Transient ischemic attack * Vascular access complications (including major bleeding events3)
Time frame: 7 days
the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 24 months and 36 months
AF recurrence is defined as: 1. Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of \> 30 seconds duration following the blanking period 2. Repeat ablation for AF/AFL/AT following the blanking period 3. Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period 4. A new Class I/III AAD or a previously failed Class I/III AAD at a dose greater than the highest historical dose for AF is needed following the blanking period
Time frame: 36 months
the rate of device and/or procedure-related SAEs from the index ablation procedure, descriptively evaluated at 12 months, 24 months, and 36 months
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Device and/or index procedure-related SAEs are defined below: * Atrioesophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction (MI) * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pneumothorax * Pulmonary edema (respiratory insufficiency) * Pulmonary vein stenosis * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Transient ischemic attack * Vascular access complications (including major bleeding events)
Time frame: 36 months