NCT04905290

Conduction System Pacing Optimized Therapy

Conduction System Pacing Optimized Therapy Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-27
• Primary completion: 2023-04-18
• Completion: 2023-11-02
• First posted: 2021-05-27
• Last updated: 2025-04-15
• Results posted: 2025-01-17

Locations

12 sites across 4 countries: United States, Ireland, Poland, United Kingdom

Regulatory

• FDA-regulated device study