60
Participants
Start Date
November 27, 2021
Primary Completion Date
April 18, 2023
Study Completion Date
November 2, 2023
Left ventricular coronary sinus (BiV) configuration
For subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay. Patients with a defibrillator will receive two additional delays LV precedes default by 30ms and LV precedes default by 60ms.
Conduction system pacing-only configuration
Conduction System Pacing (CSP) of the left bundle branch. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, and default - 60ms AV delay.
Conduction System Pacing Optimized Therapy (CSPOT) configuration
A combination of Left Ventricle pacing and Conduction System Pacing of the left bundle branch. During the acute protocol, the eight delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay, CSP precedes default by 30ms, LV precedes default by 30ms and LV precedes default by 60ms.
Geisinger Wyoming Valley Medical Center, Wilkes-Barre
Hospital of the University of Pennsylvania, Philadelphia
University of South Florida, Tampa
Vanderbilt University Medical Center, Nashville
Medtronic Inc, Mounds View
The University of Chicago Medicine, Chicago
Cardiovascular Institute of the South, Houma
Beacon Hospital, Dublin
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach, Katowice
Szpital Uniwersytecki w Krakowie, Krakow
Hammersmith Hospital, London
Great Western Hospital, Swindon
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY