TELE-SPACER Trial Comparing Pacemaker Implantation and Cardioneuroablation for Functional Atrioventricular Block in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating two different approaches to treat functional Atrio-Ventricular Block AVB, a heart condition affecting electrical conduction. This trial compares the usual elective pacemaker PM implantation recommended by guidelines with a newer method involving cardiovascular autonomic tests CAT, electrophysiologic assessment EPS, and a procedure called cardioneuroablation CNA. The study aims to see if CNA can safely and effectively treat AVB without the need for a permanent pacemaker, validating current recommendations and exploring an alternative treatment option. The trial will include at least 100 participants aged 18 to 75 with AVB and a positive atropine test. Participants will be randomly assigned to receive either early pacemaker implantation Group A or undergo CATEPS followed by CNA with possible delayed pacemaker implantation if needed Group B. Those opting out of randomization enter a registry with personalized treatment choices. Group A will receive pacemakers with telemonitoring, while Group B will get implantable loop recorders and undergo CNA under general anesthesia. If CNA is unsuccessful, pacemaker implantation may follow. Participants will be involved for at least 12 months, undergoing regular check-ups at baseline, 3, 6, and 12 months. Assessments include ECG telemonitoring, quality of life and symptom questionnaires, and cardiovascular autonomic tests with telemedicine support. Safety will be closely monitored monthly, focusing on major cardiovascular events. The study uses telemonitoring devices and provides 247 contact with specialized medical staff. Data on symptoms, fatigue, depression, and sleep will also be collected to evaluate treatment effects comprehensively.

Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block