Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 23, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Left Branch Bundle BlockRV - Right Ventricular Abnormality
Interventions
OTHER

Pacemaker Interrogation and Electrocardiogram (ECG):

Prior to the CMR study, subjects will undergo baseline interrogation of their dual chamber LBBAP to assess for appropriate device function. Lead capture characteristics will then be assessed with continuous intracardiac electrogram characteristics recorded from the atrial and ventricular lead with simultaneous 12-lead ECG rhythm strip recordings to assess for settings at which the investigators can differentiate aLBBAP, sLBBAP and nsLBBAP. Pacing output will be increased until left bundle branch area pacing with anodal capture is achieved, and then decreased until anodal capture is lost. These programming parameters will be recorded and utilized for Phase 2-3 of the CPET-CMR scan. 12-lead ECG rhythm strips of QRS morphology with each parameter set will be obtained and saved for later analysis.

OTHER

Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR

Following ECG and pacemaker analysis as above for safety, subjects will be fitted with 2 sets of MRI-compatible ECG monitoring systems a BP monitoring system , and a finger-tip pulse gating system. Imaging will be performed on a Magnetom Vida 3 Tesla scanner by trained CRM radiology technologists.

OTHER

Continuous pacemaker telemetry (CPT)

CPT will be established and supervised by a cardiac electrophysiologist to monitor for evidence of noise or artifact which may lead to inability to appropriately sense native atrial depolarization in DDD mode. Subjects with PM dependence are excluded. If noise is noted during scanning with NVP, then scanning will NOT be performed during P-synchronous pacing and will instead be performed during overdrive pacing at a rate above the patients maximal achieved heart rate with exertion during Phase 1. Thus, there is minimal risk to the subject from PM programming during CPET-CMR.

Trial Locations (1)

23298

RECRUITING

Virginia Commonwealth University, Richmond

All Listed Sponsors
lead

Virginia Commonwealth University

OTHER