An interventional study of Pacemaker Interrogation and Electrocardiogram (ECG): and Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR in Left Branch Bundle Block and RV - Right Ventricular Abnormality, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment
The goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients with pre-existing left bundle branch area pacemakers (LBBAP) programmed to an atrial sensing mode. Measurements of right ventricular, left ventricular function, and exercise capacity will be obtained at various LBBAP programming parameters at rest and during low intensity exercise. The main aims of the study are:
Conduction system pacing, namely left bundle branch area pacing (LBBAP) represents an important pacing modality introduced to avoid the deleterious effects of non-physiologic ventricular activation during chronic right ventricular pacing and /or left bundle branch block (LBBBP). Previous studies have demonstrated that LBBAP exhibits similar or superior left ventricular resynchronization compared to conventional treatment modalities, the impact of this novel pacing strategy on the right ventricle has not yet been addressed. This study aims to demonstrate the safety and feasibility of assessing LBBAP performance with a focus on right ventricular function in a novel way utilizing Cardiopulmonary Exercise Testing and Exercise Stress Cardiac Magnetic Resonance.
The investigators plan a 1-day prospective non-randomized controlled pilot study in which up to 20 subjects with left bundle branch area pacemakers with evidence of output dependent anodal capture will undergo low intensity exercise CPET-CMR at three different LBBAP settings (underlying rhythm, non-selective left bundle pacing, non-selective left bundle pacing with anodal stimulation).
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 59 interventional studies indexed under Bundle-Branch Block.
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Exclusion Criteria:
Assessment 1 (No Ventricular Pacing) will be performed with no ventricular pacing to assess baseline right and left ventricular function at rest and during exercise.
Other: Pacemaker Interrogation and Electrocardiogram (ECG): · Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR · Other: Continuous pacemaker telemetry (CPT)
Phase 2 (non-selective or selective Left Bundle Branch Area Pacing or ns/sLBBAP) will assess right and left ventricular function at rest and during exercise with non-selective or selective left bundle branch area pacing
Other: Pacemaker Interrogation and Electrocardiogram (ECG): · Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR · Other: Continuous pacemaker telemetry (CPT)
Phase 3 (Left Bundle Branch Area Pacing with Anodal Capture or aLBBAP) will assess right and left ventricular function at rest and during exercise with left bundle branch area pacing with anodal capture.
Other: Pacemaker Interrogation and Electrocardiogram (ECG): · Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR · Other: Continuous pacemaker telemetry (CPT)
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.
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.
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.
Incidence of Pacemaker Atrial (P Wave) Over-Sensed Events
Incidence of pacemaker atrial (P Wave) over sensing as derived from continuous pacemaker telemetry at optimal programmed atrial sensitivity.
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Incidence of Pacemaker Atrial (P Wave) Under-Sensed Events
Incidence of pacemaker atrial (P Wave) under sensing as derived from continuous pacemaker telemetry at optimal programmed atrial sensitivity.
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Left Ventricular Ejection Fraction (%)
Left ventricular ejection fraction (%) as measured by cardiac magnetic resonance imaging.
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Right Ventricular Ejection Fraction (%)
Right ventricular ejection fraction (%) as measured by cardiac magnetic resonance imaging.
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Slope of VO2 as a Function of Work Rate
Slope of VO2 as a function of work rate as quantified by cardiopulmonary exercise testing.
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2024 to primary completion in May 2025, 8 months.
Of 32 interventional studies with no phase under Bundle-Branch Block, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 61. This study's 8 months is below that.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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