Clinical trial NCT06601322: Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)
Official title: Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Left Branch Bundle Block
RV - Right Ventricular Abnormality
Keywords: Pacemaker
CPET-CMR
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non-randomized controlled pilot study
Primary purpose: TREATMENT

Brief 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.

Detailed description: Conduction system pacing, namely left bundle branch area pacing (LBBAP) represents an important pacing modality introduced to avoid the deleterious effects of non-physiologic ventricular activation during chronic right ventricular pacing and /or left bundle branch block (LBBBP). Previous studies have demonstrated that LBBAP exhibits similar or superior left ventricular resynchronization compared to conventional treatment modalities, the impact of this novel pacing strategy on the right ventricle has not yet been addressed. This study aims to demonstrate the safety and feasibility of assessing LBBAP performance with a focus on right ventricular function in a novel way utilizing Cardiopulmonary Exercise Testing and Exercise Stress Cardiac Magnetic Resonance.

The investigators plan a 1-day prospective non-randomized controlled pilot study in which up to 20 subjects with left bundle branch area pacemakers with evidence of output dependent anodal capture will undergo low intensity exercise CPET-CMR at three different LBBAP settings (underlying rhythm, non-selective left bundle pacing, non-selective left bundle pacing with anodal stimulation).

Eligibility 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.

Primary outcomes:
measure: Incidence of Pacemaker Atrial (P Wave) Over-Sensed Events
timeFrame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Secondary outcomes:
measure: Incidence of Pacemaker Atrial (P Wave) Under-Sensed Events
timeFrame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
measure: Left Ventricular Ejection Fraction (%)
timeFrame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
measure: Right Ventricular Ejection Fraction (%)
timeFrame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Other outcomes:
measure: Slope of VO2 as a Function of Work Rate
timeFrame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ajay Pillai
role: PRINCIPAL_INVESTIGATOR
References: