LVSP vs RVP in Patients With AV Conduction Disorders

NARecruitingINTERVENTIONAL
Enrollment

470

Participants

Timeline

Start Date

May 1, 2021

Primary Completion Date

May 1, 2025

Study Completion Date

May 1, 2025

Conditions
Cardiac PacingPacing-Induced CardiomyopathyConduction System PacingLeft Ventricular Septal PacingAtrioventricular Block
Interventions
PROCEDURE

Left ventricular septal pacing

"In the LVSP group, instead of placing the standard RV lead, the commercially available 3830 Select Secure (Medtronic, Minneapolis, USA) lead is introduced via standard transvenous approach and positioned against the right ventricular side of the IVS by using the commercially available non-deflectable septal delivery sheath (C315, Medtronic, Minneapolis, USA) under fluoroscopic guidance. Subsequently this pacing lead is advanced/screwed through the interventricular septum until the left ventricular septum is reached. Accurate lead position at the left ventricular septum will be determined anatomically using fluoroscopy, and electrically by evaluating local electrograms and changes in paced electrocardiogram morphology.~In case of unsuccessful lead positioning in the left ventricular septum, the Select Secure lead may be placed at the His bundle region (natural conduction system of the heart) or in the right ventricle according to the physician's discretion."

PROCEDURE

Right ventricular pacing

In the RVP group, the ventricular pacing lead is positioned in the right ventricle.

Trial Locations (13)

Unknown

NOT_YET_RECRUITING

Ziekenhuis Oost Limburg, Genk

NOT_YET_RECRUITING

University Hospital Gent, Ghent

RECRUITING

University Hospital Kralovske Vinohrady, Prague

NOT_YET_RECRUITING

Policlinico Casilino, Rome

RECRUITING

Noordwest Ziekenhuisgroep, Alkmaar

RECRUITING

Reinier de Graaf Gasthuis, Delft

RECRUITING

Catharina Ziekenhuis, Eindhoven

RECRUITING

Medisch Spectrum Twente, Enschede

RECRUITING

Sint Antonius Ziekenhuis, Nieuwegein

NOT_YET_RECRUITING

University Hospital Jaegellonian, Krakow

NOT_YET_RECRUITING

Hospital Universitario y Politecnico La Fe, Valencia

NOT_YET_RECRUITING

University Hospital of Geneva, Geneva

6229 ER

RECRUITING

Maastricht University, Maastricht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Medtronic

INDUSTRY

lead

Maastricht University

OTHER