Study of the Focal Pulse Ablation System to Treat Typical Atrial Flutter and Atrial Fibrillation

What this Trial Is About

Researchers are evaluating a new focal pulse ablation system for treating typical atrial flutter, a heart rhythm disorder. This prospective, single-group clinical study aims to assess the safety and effectiveness of this device in managing atrial arrhythmias. The study is sponsored by Hangzhou Dinova EP Technology Co., Ltd and focuses on patients who have experienced typical atrial flutter attacks recently recorded by ECG or Holter monitoring. The treatment involves a novel focal pulse field ablation device that performs a bidirectional block of the cavo-tricuspid isthmus CTI. This procedure is intended to interrupt abnormal electrical signals causing atrial flutter. Participants will undergo the ablation procedure, and the study will monitor procedural success immediately afterward, as well as ablation efficiency factors such as procedure time and X-ray exposure. Participants will be followed up for safety and effectiveness over a period extending to six months post-procedure. Researchers will assess acute procedural success immediately after treatment and chronic success at six months. Safety monitoring includes tracking device-related major and severe adverse events within days and months after the ablation. The study involves clinical evaluations and imaging to ensure patient well-being and treatment monitoring.

An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia