Right-sided Ablation of the Anterior Ganglionated Plexus to Prevent Recurrent Neurally Mediated Syncope A Multicenter Double-Blind Randomized Trial

What this Trial Is About

Researchers are evaluating a computed tomography CT-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrent syncope in patients with neurally mediated syncope NMS. This multicenter, double-blind, randomized trial compares this procedure against a sham control to assess its safety and effectiveness in reducing syncope episodes and improving quality of life. The study builds on previous research showing promise for less extensive cardioneuroablation methods like Cardio-neuromodulation CardNM. Participants will be randomly assigned with two-thirds receiving the active treatment involving CT-guided ablation of the anterior right-ganglionated plexus and one-third receiving a sham procedure without ablation. Both groups undergo diagnostic electrophysiology study EPS and electroanatomical mapping merged with CT images. The ablation procedure under general anesthesia targets a specific heart area until predefined endpoints are reached. Pharmacological evaluation and new diagnostic EPS are done after the procedure in both groups. Participants will complete questionnaires about syncope burden, occurrence, and quality of life at baseline and at 1, 3, 6, and 12 months. Heart rhythm monitoring will be done at baseline and during follow-up visits. Two substudies will assess blood pressure and sinus node function through 24-hour blood pressure monitoring and bicycle exercise tests. The study aims for full follow-up of 110 patients but may stop early if results are significantly different or safety concerns arise. The primary outcome is syncope-free survival over 12 months.

Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope