Outcomes and Safety of Various Conduction System Pacing Methods

RecruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

February 4, 2021

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2024

Conditions
AV BlockBundle-Branch BlockAtrial Fibrillation Rapid
Interventions
PROCEDURE

His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing

"Different active fixation leads and the dedicated delivery sheaths are introduced via standard transvenous approach under fluoroscopic guidance. His bundle potential mapping is performed in a unipolar setting with the use of the electrophysiological system for His bundle pacing. After localizing the His bundle potential, the pacing is attempted before the lead fixation to confirm HB capture. The lead is then screwed into position. Acute HBP threshold ≤ 2.5V at 1ms is considered acceptable. On the other hand, the initial site for LBBP is approximately 1-1.5 cm distal to the HBP lead position in the RV septum along the line between the HBP site and RV apex in the right anterior oblique (30°) fluoroscopic view. Bachmann bundle pacing (upper atrial septum) will be performed with the J-stylet modification technique or with specialized catheter method using the SelectSecure active fixation lead.~Stepwise approach for conduction pacing will also be tested."

Trial Locations (1)

1000

RECRUITING

University Medical Centre Ljubljana - Cardiology department, Ljubljana

All Listed Sponsors
lead

University Medical Centre Ljubljana

OTHER