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Systolic Heart FailureNCT05884411

Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response

A study testing Left bundle branch area pacing and Cardiac MRI in people with Systolic Heart Failure and Heart Failure With Reduced Ejection Fraction, run by VA Office of Research and Development at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study aims to investigate whether the investigators can improve heart function in patients with heart failure who have undergone cardiac resynchronization therapy, but have not had an improvement in their heart function at least one year after the procedure. Read more about this study

Who is it for?
Any age
What is being tested?
Left bundle branch area pacing and Cardiac MRI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
30 Apr 2023to 5 Aug 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All Veterans in this study will have undergone CRT at least 12 months prior to enrollment and determined to have non-response by all the following criteria:
  • Lack of improvement in New York Heart Association (NYHA) class
  • Lack of LVEF increase by > 5%
  • Lack of decrease in LVESV by > 15%

Who cannot join

  • Unable to understand or provide informed consent
  • Unable or unwilling to participate in the protocol or comply with any of its components
  • Pregnant women
  • Known cancer patients, actively receiving chemotherapy
  • Patients unable to pass MRI safety screening (intra-orbital metallic foreign bodies, severe claustrophobia, etc)
  • Patients with anatomical difficulties for implanting LBBAP
  • Patients with high risk of procedure-related infection
  • Immunocompromised patients

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309

Other trials in United States

About this study

Official title: Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-response in Patients With Heart Failure: A Randomized Controlled Trial

This study aims to investigate whether the investigators can improve heart function in patients with heart failure who have undergone cardiac resynchronization therapy, but have not had an improvement in their heart function at least one year after the procedure. The investigators will evaluate whether placing a new pacing lead (electrode) in a different part of the heart may increase heart function and decrease heart failure symptoms.

Read the detailed description

Heart failure is one of the leading causes of death, hospitalization and poor quality of life among Veterans. For many Veterans despite receiving maximal medical therapy for heart failure with reduced ejection fraction (HFrEF), their cardiac function and functional capacity markedly decreases and they develop delays and blocks in their intrinsic conduction system (i.e. left bundle branch block). These patients then meet criteria for cardiac resynchronization therapy (CRT), which has been shown to improve cardiac function. However, up to 40% of patients who undergo CRT do not experience the expected improvement in cardiac function or clinical improvement, and this is termed "non-response".

A critical limitation of traditional CRT is that the leads do not directly utilize the heart's intrinsic conduction tissue, called the His-Purkinje system. An extensive web of conduction tissue capable of transmitting the electrical signals all over the ventricles within milliseconds, the His-Purkinje system conducts electrical stimuli much faster than conduction through a usual myocardial cell. The left bundle branch is a component of the His-Purkinje system. As such, electrophysiologic therapies that directly activate the left bundle branch area (LBBAP) have emerged as possible solutions to the problem of non-response to CRT. Although data suggests that in patients with complete LBBB, LBBAP can better optimize electrical synchrony and improve cardiac function compared to traditional bi-ventricular CRT, the efficacy has not been studied in CRT non-responders.

Currently, the most frequently used technique for assessment of the left ventricle is echocardiography because it is widely available. However, several studies have demonstrated that cardiac MRI (CMR) is superior to echocardiography in measuring left ventricle ejection fraction, particularly in terms of interstudy reproducibility. Recent studies have also demonstrated CMR imaging to be safe even in patients with non-MRI-conditional pacemakers and defibrillators. Studies have also observed that patients undergoing MRI with non-MRI-conditional pacemakers or ICDs neither experienced device/lead failure nor were they at increased risk by undergoing MRI. Despite established safety of CMR in patients with cardiac devices, it is not being routinely performed because there are concerns that the devices will cause field inhomogeneity resulting in magnetic susceptibility artifacts and non-diagnostic image quality. However, these concerns are overcome by utilizing contemporary imaging protocols with gradient echo sequences as opposed to standard steady-state free precession. By using these new protocols for CMR in this study, the investigators aim to establish the feasibility of CMR to prospectively assess cardiac function at baseline and during follow-up in patients with cardiac devices (i.e. that the image quality in subjects with implantable devices is adequate and not undermined by image artifact).

Being tested
Left bundle branch area pacing, Cardiac MRI
Keywords
Heart Failure, CRT, LBBAP, Non-response, Cardiac MRI, CMR, Left bundle branch area pacing, cardiac resynchronization therapy
Medical subject headings
Heart Failure, Systolic, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left bundle branch area pacingDevice

    Also called LBBAP

    A cardiac pacing electrode is inserted into the left bundle branch area of the myocardium via a transvenous approach.

  • Cardiac MRIDiagnostic test

    Also called CMR

    A diagnostic imaging test using magnetic resonance imaging to evaluate cardiac function.

Study groups in NCT05884411
Study groupRoleWhat they receive
LBBAPExperimentalThis arm will investigate improvement in cardiac function following placement of the LBBA pacing electrode in half the patients.
Receives: Device: Left bundle branch area pacing
Cardiac MRI with devicesExperimentalThis arm will investigate the feasibility of cardiac MRI to be used to measure cardiac function in patients with cardiac devices.
Receives: Diagnostic Test: Cardiac MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction by echocardiography

    CRT non-response will be evaluated by echocardiography to assess left ventricular ejection fraction (LVEF). LVEF is reported as a percent.

    Measured: 6 months

Secondary outcomes (2)
  1. Left ventricular ejection fraction by cardiac MRI

    Cardiac MRI (CMR) will also be used to assess left ventricular ejection fraction (LVEF). LVEF is reported as a percent.

    Measured: 6 months

  2. Interventricular mechanical delay measurement by 2D speckle-tracking echocardiography

    Left ventricular synchrony will be assessed by measuring the interventricular mechanical delay (measured in ms) using 2D speckle-tracking echocardiography.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start30 Apr 2023
  3. Primary completion5 Aug 2025
  4. Study completion5 Aug 2025

Why it stopped: unsuccessful recruitment

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized to either receive the new pacing lead in the left bundle branch area or continue current cardiac therapy (CRT) with biventricular CRT
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884411
Sponsor's protocol ID
CARA-001-22F
Other IDs
CX002525
Status last verified
Aug 2025
First submitted
28 Apr 2023
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Left bundle branch area pacing and Cardiac MRI in people with Systolic Heart Failure and Heart Failure With Reduced Ejection Fraction, run by VA Office of Research and Development 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Aug 2025. 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 was withdrawn before enrolling participants, so there are no results.

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?

Left ventricular ejection fraction by echocardiography (time frame: 6 months). 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 11 Aug 2025.

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