Left Branch Bundle BlockFOCUS-RightNCT06601322
Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)
A study testing Pacemaker Interrogation and Electrocardiogram (ECG):, Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR and Continuous pacemaker telemetry (CPT) in people with Left Branch Bundle Block and RV - Right Ventricular Abnormality, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Branch Bundle Block, RV - Right Ventricular Abnormality
- What is being tested?
- Pacemaker Interrogation and Electrocardiogram (ECG):, Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR and Continuous pacemaker telemetry (CPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of dual chamber LBBAP implantation
- presence of anodal capture with bipolar pacing configuration as determined at pacing implant.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)
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.
Read the 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).
- Being tested
- Pacemaker Interrogation and Electrocardiogram (ECG):, Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR, Continuous pacemaker telemetry (CPT)
- Keywords
- Pacemaker, CPET-CMR
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (ExeCMROther
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 group | Role | What they receive |
|---|---|---|
| No Ventricular Pacing (NVP) | Other | 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. Receives: Other: Pacemaker Interrogation and Electrocardiogram (ECG):; Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR; Other: Continuous pacemaker telemetry (CPT) |
| Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP) | Active comparator | 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 Receives: Other: Pacemaker Interrogation and Electrocardiogram (ECG):; Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR; Other: Continuous pacemaker telemetry (CPT) |
| Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP) | Experimental | 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. Receives: Other: Pacemaker Interrogation and Electrocardiogram (ECG):; Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR; Other: Continuous pacemaker telemetry (CPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pacemaker Atrial (P Wave) Over-Sensed Events
Incidence of pacemaker atrial (P Wave) over sensing as derived from continuous pacemaker telemetry at optimal programmed atrial sensitivity.
Measured: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Secondary outcomes (3)
Incidence of Pacemaker Atrial (P Wave) Under-Sensed Events
Incidence of pacemaker atrial (P Wave) under sensing as derived from continuous pacemaker telemetry at optimal programmed atrial sensitivity.
Measured: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Left Ventricular Ejection Fraction (%)
Left ventricular ejection fraction (%) as measured by cardiac magnetic resonance imaging.
Measured: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Right Ventricular Ejection Fraction (%)
Right ventricular ejection fraction (%) as measured by cardiac magnetic resonance imaging.
Measured: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Aug 2024
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Branch Bundle BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective non-randomized controlled pilot study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Pillai, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601322
- Sponsor's protocol ID
- HM20028599
- Acronym
- FOCUS-Right
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)
- ClinicalTrials.gov ID
- NCT06601322
- Acronym / sponsor ID
- FOCUS-Right / HM20028599
- Keywords
- Pacemaker, CPET-CMR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective non-randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| No Ventricular Pacing (NVP) | Other | Other: Pacemaker Interrogation and Electrocardiogram (ECG):, Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR, Other: Continuous pacemaker telemetry (CPT)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. |
| Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP) | Active comparator | Other: Pacemaker Interrogation and Electrocardiogram (ECG):, Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR, Other: Continuous pacemaker telemetry (CPT)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 |
| Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP) | Experimental | Other: Pacemaker Interrogation and Electrocardiogram (ECG):, Other: Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR, Other: Continuous pacemaker telemetry (CPT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of dual chamber LBBAP implantation
- presence of anodal capture with bipolar pacing configuration as determined at pacing implant.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker Interrogation and Electrocardiogram (ECG):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. | Other | Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP), No Ventricular Pacing (NVP), Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP) |
| Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMRFollowing 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. | Other | Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP), No Ventricular Pacing (NVP), Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP) |
| Continuous pacemaker telemetry (CPT)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. | Other | Left Bundle Branch Area Pacing with Anodal Capture (aLBBAP), No Ventricular Pacing (NVP), Non-selective or Selective Left Bundle Branch Area Pacing (nsLBBAP) |
Primary outcome
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.
Incidence of pacemaker atrial (P Wave) over sensing as derived from continuous pacemaker telemetry at optimal programmed atrial sensitivity.
3 secondary outcomes
Incidence of Pacemaker Atrial (P Wave) Under-Sensed Events
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Left Ventricular Ejection Fraction (%)
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Right Ventricular Ejection Fraction (%)
Time frame: Day 1: From beginning of CPET-CMR imaging procedure to end of CPET-CMR imaging procedure on study day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Pillai principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker Interrogation and Electrocardiogram (ECG):, Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR and Continuous pacemaker telemetry (CPT) in people with Left Branch Bundle Block and RV - Right Ventricular Abnormality, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.