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Tiny trial tests which defibrillator is best for heart muscle disease

NCT ID NCT05938283

Knowledge-focused Sponsor: Barts & The London NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study enrolled 5 people with hypertrophic cardiomyopathy who needed an implantable cardioverter defibrillator (ICD) but did not require pacing. Participants were randomly assigned to receive either a subcutaneous ICD (placed under the skin) or a transvenous ICD (with leads in the veins). The main goals were to see how many people could be recruited per month and to track inappropriate shocks and device complications over 12 months. This small study is a first step toward planning a larger trial.

What this could mean

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

Active substance
Implantable cardioverter defibrillator (ICD)
What this could lead to
If successful, this pilot could pave the way for a larger trial to determine which ICD type is safer and more effective for people with hypertrophic cardiomyopathy.
What could go wrong
This is a very small pilot study with only 5 participants, so results may not apply to all patients. The main goal is to test recruitment feasibility, not to prove which device is better.

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

5 people

The number who actually took part.

Started

Jan 2024

Finished

Jan 2026

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: * Hypertrophic Cardiomyopathy and a referred for ICD therapy with no pacing requirement. Exclusion Criteria: * Patients with sustained ventricular tachycardia less than 170 bpm * Patients having an indication for pacing therapy. E.g. sick sinus syndrome. * Patients failing appropriate QRS/T-wave sensing with the automated S-ICD ECG automated patient screening provided by Boston Scientific * A minimum of 1 sensing vector passing in supine, standing. * Patients with incessant ventricular tachycardia * Patients who have had a previous ICD implant * Patient who receives cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy * Patients with a serious known concomitant disease with a life expectancy of less than one year * Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.) * Patients who are unable to give informed consent * Patients who are not suitable for TV-ICD implantation, according to the discretion of the physician, are not screened for enrolment (SVC occlusion).

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease hypertrophic cardiomyopathy

As listed by the trial registrant

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

Hypertrophic cardiomyopathy Implantable cardioverter ventricular lead dysfunction or complication Implantable defibrillator user Ventricular arrythmia

Contacts and locations

Locations

  • St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

More trials for these conditions

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