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

Conditions

• Left Branch Bundle Block
• RV - Right Ventricular Abnormality

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pacemaker Interrogation and Electrocardiogram (ECG): — OTHER
  Prior to the CMR study, subjects will undergo baseline interrogation of their dual chamber LBBAP to assess for appropriate device function. Lead capture characteristics will then be assessed with continuous intracardiac electrogram characteristics recorded from the atrial and ventricular lead with simultaneous 12-lead ECG rhythm strip recordings to assess for settings at which the investigators can differentiate aLBBAP, sLBBAP and nsLBBAP. Pacing output will be increased until left bundle branch area pacing with anodal capture is achieved, and then decreased until anodal capture is lost. These programming parameters will be recorded and utilized for Phase 2-3 of the CPET-CMR scan. 12-lead ECG rhythm strips of QRS morphology with each parameter set will be obtained and saved for later analysis.
• Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR — OTHER
  Following ECG and pacemaker analysis as above for safety, subjects will be fitted with 2 sets of MRI-compatible ECG monitoring systems a BP monitoring system , and a finger-tip pulse gating system. Imaging will be performed on a Magnetom Vida 3 Tesla scanner by trained CRM radiology technologists.
• Continuous pacemaker telemetry (CPT) — OTHER
  CPT will be established and supervised by a cardiac electrophysiologist to monitor for evidence of noise or artifact which may lead to inability to appropriately sense native atrial depolarization in DDD mode. Subjects with PM dependence are excluded. If noise is noted during scanning with NVP, then scanning will NOT be performed during P-synchronous pacing and will instead be performed during overdrive pacing at a rate above the patients maximal achieved heart rate with exertion during Phase 1. Thus, there is minimal risk to the subject from PM programming during CPET-CMR.

Study Details

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.

Key Dates

Start date

Aug 23, 2024

Status verified

Apr 2026

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: No Ventricular Pacing (NVP)
  Assessment 1 (No Ventricular Pacing) will be performed with no ventricular pacing to assess baseline right and left ventricular function at rest and during exercise.
• Active Comparator: Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP)
  Phase 2 (non-selective or selective Left Bundle Branch Area Pacing or ns/sLBBAP) will assess right and left ventricular function at rest and during exercise with non-selective or selective left bundle branch area pacing
• Experimental: Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP)
  Phase 3 (Left Bundle Branch Area Pacing with Anodal Capture or aLBBAP) will assess right and left ventricular function at rest and during exercise with left bundle branch area pacing with anodal capture.

Primary Outcome Measure

Incidence of Pacemaker Atrial (P Wave) Over-Sensed Events [ Time Frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day. ]

Central Contacts

• Ajay Pillai
  (478) 957-2109
  [email protected]
• Melissa Sears
  804-828-1601
  [email protected]

Locations (1)

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