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

Description

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.

Conditions

Left Branch Bundle Block, RV - Right Ventricular Abnormality

Study Overview

Study Details

Study overview

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.

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

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

Condition
Left Branch Bundle Block
Intervention / Treatment

-

Contacts and Locations

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Ajay Pillai, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2025-09