Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2026

Conditions
Atrioventricular Block
Interventions
PROCEDURE

Pacemaker implantation

Elective pacemaker implantation (DDDR) for functional AVB according to the 2021 ESC Guidelines for Cardiac Pacing

PROCEDURE

Cardioneuroablation (CNA)

"Experimental method; elective implantable loop recorder (ILR) and biatrial, binodal, atomically and electroanatomically guided CNA with extracardiac vagal nerve stimulation (ECVS) prior and after procedure monitoring (disappearance of ECVS-induced AVB with the goal of achieving post-procedure and maintaining a target heart rate \> 50 beats per minute). CNA procedure is performed with radio-frequency generators and irrigated catheters and with support of 3D-electroanatomic mapping system.~CNA group will receive external ECG recorders. The major reason for external ECG recorders is to provide documentation of clinical AVB, as well as monitoring of patients before and after CNA (or PM implantation, if accepted). In case of severe AVB symptoms always the emergency system will be called."

Trial Locations (2)

41-300

RECRUITING

American Heart of Poland, Dąbrowa Górnicza

39-300

RECRUITING

American Heart of Poland, Mielec

All Listed Sponsors
lead

American Heart of Poland

OTHER