Actively Recruiting
Functional Outcomes in Conduction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)
Led by Virginia Commonwealth University · Updated on 2026-04-16
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients who have left bundle branch area pacemakers (LBBAP) programmed to an atrial sensing mode. The study focuses on measuring right and left ventricular function and exercise capacity at different LBBAP programming settings. It is a prospective pilot study designed to generate preliminary data on these heart functions during rest and low intensity exercise. The study involves a one-day assessment with up to 20 subjects who have dual chamber LBBAP devices showing anodal capture. Participants will be tested under three different pacing settings: no ventricular pacing to establish baseline heart function, non-selective or selective left bundle branch area pacing (ns/sLBBAP), and left bundle branch area pacing with anodal capture (aLBBAP). Before imaging, pacemaker interrogation and electrocardiogram (ECG) analyses will be performed to determine optimal programming parameters. During exercise, cardiac magnetic resonance imaging will be conducted with MRI-compatible monitoring systems. Throughout the study day, participants will undergo continuous pacemaker telemetry monitoring to detect any sensing issues during the CPET-CMR procedure. Researchers will measure pacemaker atrial sensing events and assess left and right ventricular ejection fractions at rest and during exercise. The total participation includes baseline device checks, exercise testing with imaging, and safety monitoring under medical supervision. The study will help understand the impact of different LBBAP settings on heart function and exercise capacity over this single study visit.
CONDITIONS
Brief Title
Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of dual chamber left bundle branch area pacemaker implantation
- Presence of anodal capture with bipolar pacing configuration as determined at pacing implant
You will not qualify if you...
- Known history of chronotropic incompetence
- High degree or complete heart block
- Inability to tolerate no ventricular pacing during initial device interrogation
- Pregnancy
- Inability to undergo MRI or exercise using supine bicycle at target work-load
- Presence of MRI unsafe pacemaker components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants undergo a single-day study visit involving pacemaker interrogation, cardiopulmonary exercise testing, and exercise stress cardiac magnetic resonance imaging to assess ventricular function under different pacing settings.
1 study day visit (in-person)
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
A
Ajay Pillai
M
Melissa Sears
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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