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FOCUS-Right Study: Pacemakers and Heart Function

This study, called FOCUS-Right, is looking at how pacemakers that stimulate the left bundle branch area (LBBAP) affect your heart, especially the right side. Researchers want to see if it's safe and possible to combine exercise stress cardiac MRI (a special heart scan during exercise) with cardiopulmonary exercise testing (a test of your heart and lung fitness) in people who already have these pacemakers. They will measure how well your heart pumps blood and your exercise ability at different pacemaker settings, both at rest and during light exercise. The main goal is to show that these tests can be safely done together in patients with LBBAP pacemakers. This study is for adults with a dual chamber LBBAP pacemaker and specific pacing characteristics.

Study design
This is a single-center pilot study with up to 20 participants. It is not randomized.
What's involved
You will undergo a pacemaker check, an electrocardiogram (ECG), and then a combined exercise stress cardiac MRI and cardiopulmonary exercise test on one study day. Continuous pacemaker monitoring will also be used.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured on Day 1, from the beginning to the end of the CPET-CMR imaging procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06601322

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

Completed
NAAges 18+InterventionalTreatment
Virginia Commonwealth University
~5 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Pacemaker Interrogation and Electrocardiogram (ECG):Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMRContinuous pacemaker telemetry (CPT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Pacemaker Atrial (P Wave) Over-Sensed Events
Measured over Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.

Conditions

Left Branch Bundle Block
RV - Right Ventricular Abnormality

Explore related trials

Left bundle branch blockRight ventricular abnormality

NCT06601322

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Virginia Commonwealth University

    Richmond, Virginiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ajay Pillai · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

presence of dual chamber LBBAP implantation
presence of anodal capture with bipolar pacing configuration as determined at pacing implant.

Exclusion

Known history of chronotropic incompetence
high degree or complete heart block
inability to tolerate NVP during initial device interrogation
pregnancy
inability to undergo MRI or exercise utilizing supine bicycle at target work-load
presence of MRI unsafe pacemaker components.

What this trial measures

  • Incidence of Pacemaker Atrial (P Wave) Over-Sensed EventsDay 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.

    Incidence of pacemaker atrial (P Wave) over sensing as derived from continuous pacemaker telemetry at optimal programmed atrial sensitivity.