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Can MRI scans decide who needs a defibrillator?

NCT ID NCT07791407

Disease control Sponsor: Velammal Medical College Hospital and Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial compares two pacing approaches for people with heart failure and a very weak heart pump (ejection fraction 35% or less) due to non-ischemic cardiomyopathy. One method uses left bundle branch pacing without a defibrillator, while the other uses standard biventricular pacing with a defibrillator. Researchers use MRI scans to categorize each patient's risk and then randomly assign them to one of the two treatments. The goal is to see if the less invasive pacing alone can match the defibrillator approach in preventing death, heart failure hospitalizations, and dangerous heart rhythms, while also improving heart function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
left bundle branch pacing (device) and biventricular pacing with defibrillator (device)
What this could lead to
If successful, this could show that a less invasive pacing method without a defibrillator is as effective as a defibrillator-based approach for certain heart failure patients, potentially reducing complications and improving quality of life.
What could go wrong
The trial is relatively small and early, and the outcome depends on MRI-based risk assessment, which may not perfectly predict who needs a defibrillator. There are also risks associated with any cardiac device implantation, such as infection or lead complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with age ≥18 years 2. Typical left bundle branch block as defined by Strauss criteria with LVEF ≤35% 3. Heart failure symptoms despite guideline directed medical therapy (GDMT) Exclusion Criteria: 1. Patients with angiographic evidence of significant coronary artery disease requiring revascularisation. In patients with significant CAD, LVEF will be re-assessed 3 months after revascularisation to decide about CRT 2. Patients with associated uncorrected congenital or valvular heart disease 3. Expected life-expectance of \<12 months due to associated comorbidities 4. Patients with contrast allergy 5. Baseline non-LBBB morphology 6. Renal dysfunction which limits the acquisition of CMR with contrast 7. Pregnant or lactating women 8. Patients who are unable to comply with study protocol

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non ischemic cardiomyopathy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Velammal Medical College Hospital and Research Institute

    RECRUITING

    Madurai, Tamil Nadu, 625009, India

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