Clinical Trial

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

Study acronym: FOCUS-Right
Completed
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 8 changes
critical Trial completed 2026-08-13
notable Enrollment reduced: 20 -> 5 participants 2026-08-13
notable Primary completion moved earlier: 2026-07 -> 2025-05-13 2026-08-13
minor Completion moved earlier: 2026-07 -> 2025-05-13 2026-08-13
notable Primary completion pushed: 2026-05 -> 2026-07 2026-06-18
minor Completion pushed: 2026-05 -> 2026-07 2026-06-18
notable Primary completion pushed: 2026-03 -> 2026-05 2026-04-17
minor Completion pushed: 2026-03 -> 2026-05 2026-04-17
Trial Details
NCT Number NCT06601322
Lead Sponsor Virginia Commonwealth University
Conditions Left Branch Bundle Block, RV - Right Ventricular Abnormality
Enrollment 5 participants
Start Date 2024-08-23
Primary Completion 2025-05-13 (estimated)
Study Completion 2025-05-13 (estimated)
Updated on ClinicalTrials.gov 2026-08-12