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
Qualifiers
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
Treatments tested in this trial
- Pacemaker Interrogation and Electrocardiogram (ECG):
- Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR
- Continuous pacemaker telemetry (CPT)
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov