Study of Catheter Ablation of Cardiac Ganglionated Plexi to Treat Significant Bradycardia in Adults

What this Trial Is About

Researchers are exploring the potential of cardioneuroablation, a minimally invasive catheter ablation technique targeting cardiac ganglionated plexi, for treating significant vagally-mediated bradycardia. This condition involves abnormally slow heart rates caused by overactive vagal nerve signals. The study combines basic science and clinical investigation to address the current lack of high-level evidence on the safety and effectiveness of this therapy, aiming to establish a reliable, evidence-based treatment strategy. This approach avoids permanent device implantation and focuses on suppressing abnormal vagal activity that contributes to bradycardia symptoms like syncope and fatigue. The study randomly assigns participants to one of two groups one receiving cardioneuroablation targeting atrial ganglionated plexi through a catheter procedure performed under local anesthesia with sedation, and the other undergoing a sham procedure without ablation or transseptal puncture. The ablation involves catheter insertion through the femoral vein, positioning in the heart guided by imaging, and sequentially ablating specific nerve clusters in the atria. The sham procedure mimics the preparation and catheter placement but does not include ablation, with participants wearing headphones and an eye mask to maintain blinding. Participants will be monitored with 24-hour ambulatory electrocardiograms at baseline and at 1, 3, 6, and 12 months post-procedure to measure average heart rate, PR interval, and heart rate variability. Quality of life will be assessed with a standardized health survey at baseline and 12 months. The study emphasizes rigorous design and standardized procedures to ensure reliable and reproducible results. Participant involvement includes multiple follow-up visits over a year to assess heart rhythm changes, symptoms, and overall wellbeing, supporting a comprehensive evaluation of the interventions impact.

Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia