Evaluating Cardioneuroablation Versus Permanent Pacemaker Therapy in Adults with Symptomatic Bradycardia and Implanted Pacemakers

What this Trial Is About

Researchers are evaluating cardioneuroablation CNA as an alternative treatment to permanent pacemaker PM therapy for patients with symptomatic bradycardia caused by sinus node dysfunction SND or atrioventricular block AVB. The study aims to assess the safety and effectiveness of CNA in allowing patients to discontinue or optimize PM therapy. It also seeks to develop a diagnostic method for selecting suitable patients for CNA and PM therapy discontinuation. Participants are randomly assigned to one of three groups Group 1 receives invasive electrophysiology study EPS, extracardiac vagal stimulation ECVS, CNA, continued PM therapy, and implantable loop recorder ILR implantation Group 2 undergoes EPS, ECVS, continued PM therapy, and ILR implantation without initial CNA but with delayed CNA later in the study Group 3 is observed without intervention. The study includes follow-up hospitalizations and visits involving repeated EPS, ECVS, CNA if needed, PM reprogramming, and non-invasive assessments of CNA effectiveness and bradycardia symptoms. Throughout the 18-month study, participants undergo regular evaluations including ECG, PM checks, laboratory tests, 24-hour Holter ECG, ILR monitoring, and symptom assessments. Researchers monitor pacing percentages, bradycardia symptoms, and possible adverse effects. Patients with minimal or no pacing needs may have their pacemakers set to pacing-off modes. The study also collects blood samples for future research and includes detailed follow-up visits every 3 months for assessment and potential qualification for pacemaker therapy discontinuation or lead extraction.

Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.