Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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:
* Demonstrate the safety and feasibility of performing CPET-CMR in patients with pre-existing LBBAP programmed to P-synchronous ventricular pacing mode. * Generate preliminary data evaluating differences in RV function, LV function, and exercise capacity during various pacemaker programming settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
presence of dual chamber LBBAP implantation
presence of anodal capture with bipolar pacing configuration as determined at pacing implant.
Disqualifiers
Known history of chronotropic incompetence
high degree or complete heart block
inability to tolerate NVP during initial device interrogation
pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Pacemaker Interrogation and Electrocardiogram (ECG):
Other interventionPrior 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.
Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR
Other interventionFollowing 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.
Continuous pacemaker telemetry (CPT)
Other interventionCPT 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.
Treatment groups
20 Participants
are divided into 3 treatment groupsGroup A: No Ventricular Pacing (NVP)Other 3 interventions
Group B: Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP)Active comparator 3 interventions
Group C: Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.Other outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov