470
Participants
Start Date
May 1, 2021
Primary Completion Date
May 1, 2025
Study Completion Date
May 1, 2025
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."
Right ventricular pacing
In the RVP group, the ventricular pacing lead is positioned in the right ventricle.
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
RECRUITING
Maastricht University, Maastricht
Collaborators (1)
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Medtronic
INDUSTRY
Maastricht University
OTHER