Conduction System Pacing Optimized Therapy

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 27, 2021

Primary Completion Date

April 18, 2023

Study Completion Date

November 2, 2023

Conditions
Heart Failure
Interventions
DEVICE

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.

DEVICE

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.

DEVICE

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.

Trial Locations (12)

18711

Geisinger Wyoming Valley Medical Center, Wilkes-Barre

19104

Hospital of the University of Pennsylvania, Philadelphia

33606

University of South Florida, Tampa

37232

Vanderbilt University Medical Center, Nashville

55112

Medtronic Inc, Mounds View

60637

The University of Chicago Medicine, Chicago

70360

Cardiovascular Institute of the South, Houma

D18 Ak68

Beacon Hospital, Dublin

40-635

Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach, Katowice

30-688

Szpital Uniwersytecki w Krakowie, Krakow

W12 0HS

Hammersmith Hospital, London

SN3 6BB

Great Western Hospital, Swindon

All Listed Sponsors
lead

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

NCT04905290 - Conduction System Pacing Optimized Therapy | Biotech Hunter | Biotech Hunter