Study on Safety and Effectiveness of High Power Short Duration Radiofrequency Ablation for Treating Paroxysmal or Persistent Atrial Fibrillation in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation PVI using high power short duration HPSD radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation AF. This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedures overall safety and efficacy.

AF Ablation With High Power Short Duration RF