Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation

NARecruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

July 18, 2023

Primary Completion Date

December 25, 2025

Study Completion Date

December 25, 2026

Conditions
Heart FailureTachycardia-induced CardiomyopathyAtrial Fibrillation
Interventions
DEVICE

Biventricular pacemaker implantation

Implantation of permanent pacemaker with biventricular stimulation with or without defibrillator lead placement using standard techniques. The right ventricle lead will be positioned in the RV apex or septum, while the left ventricle lead will be delivered to the most appropriate coronary sinus tributary, preferably posterolateral or lateral vein.

DEVICE

Conduction system pacing device implantation

Left bundle branch pacing (LBBP) will be the preferred pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory. If LBBP will be unobtainable, His bundle pacing (HBP) implantation will be attempted. His bundle potential mapping will be performed with the use of the electrophysiological system and under fluoroscopic guidance. Distal HB potential with a large ventricular signal and a small atrial signal will be targeted before the pacing lead will be screwed into position. Backup RV lead will be mandatory for all patients receiving HBP devices.

PROCEDURE

AV node ablation

Atrioventricular node ablation (AVNA) will be performed following pacemaker implantation (preferably during the same hospitalization). After femoral vein access will be obtained, the ablation catheter will be positioned to the presumed area of the AV node in the mid-septum under fluoroscopy. The location will be optimized according to the intracardiac electrograms. Ablation will be performed in a temperature-controlled mode. Successful AVNA will be recognized with an abrupt drop of heart rate to 40 bpm and will continue for 60 seconds thereafter.

Trial Locations (10)

1000

RECRUITING

University Medical Centre Ljubljana - Department of cardiology, Ljubljana

RECRUITING

University Medical Centre Ljubljana - Department of cardiovascular surgery, Ljubljana

1134

RECRUITING

Central-Hospital of Northern Pest - Military Hospital, Budapest

Unknown

RECRUITING

University Hospital Graz - Divison of Cardiology, Graz

RECRUITING

Hospital Oost-Limburg (Hartzentrum Genk), Genk

RECRUITING

Acibadem City Clinic Tokuda Hospital - Department of Invasive Electrophysiology, Sofia

RECRUITING

Clinical Hospital Center Rijeka, Rijeka

RECRUITING

University Hospital of Split, Split

RECRUITING

University Hospital Centre Zagreb, Zagreb

RECRUITING

County Clinical emergency hospital of Brasov - Department of Interventional Cardiology, Brasov

All Listed Sponsors
lead

University Medical Centre Ljubljana

OTHER