Evaluating heart function in patients with specific pacemakers during exercise
Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)
This study is testing how well people with specific pacemakers can exercise and how their heart functions during that exercise to help improve future treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06601322 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and feasibility of conducting simultaneous cardiopulmonary exercise testing and cardiac magnetic resonance imaging in patients with left bundle branch area pacemakers. The study will measure right and left ventricular function and exercise capacity at different pacemaker settings during low-intensity exercise. By focusing on the impact of conduction system pacing on right ventricular function, the trial seeks to generate preliminary data that could inform future treatment strategies. The study will involve a one-day, non-randomized controlled pilot approach with up to 20 participants.
Who should consider this trial
Good fit: Ideal candidates include individuals with dual chamber left bundle branch area pacemakers who exhibit anodal capture.
Not a fit: Patients with known chronotropic incompetence, high degree or complete heart block, or those unable to tolerate exercise or MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of pacemaker settings on heart function, potentially leading to improved patient outcomes.
How similar studies have performed: Previous studies have shown that left bundle branch area pacing can improve left ventricular function, but the specific impact on right ventricular function remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * presence of dual chamber LBBAP implantation * presence of anodal capture with bipolar pacing configuration as determined at pacing implant. Exclusion Criteria: * 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.
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Ajay Pillai — Virginia Commonwealth University
- Study coordinator: Ajay Pillai
- Email: ajay.pillai@vcuhealth.org
- Phone: (478) 957-2109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.