The objective of this clinical trial is to collect safety and effectiveness data for the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the APAC patient population for the treatment of drug refractory, symptomatic persistent atrial fibrillation when following standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
The PerAF APAC trial is a prospective, single arm, non-randomized, observational, post-market clinical investigation. Approximately 100 subjects will be enrolled at up to 15 sites in South Korea, Singapore, Hong Kong, Taiwan, and India. Centers in other countries within APAC may be approached for participation in the clinical investigation as needed. Subjects will be followed for 15-months after their initial ablation procedure. The primary effectiveness and safety endpoints will be evaluated through 15-months. A core lab will independently assess AF/Atrial Flutter (AFL)/(Atrial tachycardia (AT) recurrence via Holter monitoring at the 6-month and 15-month follow-up visits. All serious adverse events (SAEs) will be independently adjudicated by qualified physicians not participating in the trial
Study Type
OBSERVATIONAL
Enrollment
82
TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
Prince of Wales Hospital
Hong Kong, Hong Kong
National Heart Centre Singapore
Singapore, Singapore
National University Hospital
Singapore, Singapore
Sejong Hospital
Bucheon-si, South Korea
Rate of Device and/or Procedure-related Serious Adverse Events
device and/or procedure-related serious adverse events are pre-defined as below with onset within 7-days of any ablation procedure that uses the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure) * Atrioesophageal fistula - assessed through 15 months * Cardiac tamponade/perforation - assessed through 15 months * Death * Heart block * Myocardial infarction (MI) * Pericarditis - pleuritic symptoms \>7 days and/or requires hospitalization \>24 hrs for reasons other than observational purposes only * Phrenic nerve injury resulting in diaphragmatic paralysis * Pneumothorax * Pulmonary edema (respiratory insufficiency) * Pulmonary vein stenosis - assessed through 15 months * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vascular access complications (including major bleeding events)
Time frame: Through 7-days
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Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Centre
Soeul, South Korea
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Phramongkutklao Hospital
Bangkok, Thailand