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Micro heart lead shows promise in early test

NCT ID NCT04156412

Disease control Sponsor: University Hospital, Rouen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a very small, specially shaped heart lead (less than 2 French) in 39 adults getting a cardiac resynchronization therapy device. The goal was to see if the lead could successfully pace the left ventricle from two distant spots. Researchers measured pacing success, electrical performance, and any problems during the implant procedure.

What this could mean

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

Active substance
new micro multipolar heart lead (device)
What this could lead to
If successful, this tiny lead could make cardiac resynchronization therapy more precise and easier to implant for heart failure patients.
What could go wrong
This is a very small, early pilot study with only 39 patients. The lead may not work better than standard leads, and there are risks from the implant procedure itself.

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

39 people

The number who actually took part.

Started

Jan 2020

Finished

Sep 2020

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: * Male or female patient aged ≥18 years old. * Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1. * Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD). * Signed and dated informed consent. Exclusion Criteria: * Class IV of NYHA (ambulatory or not). * Allergy to contrast media used for imaging during cardiac catheterization. * Severe Renal Failure (clearance of creatinine according to Modification of diet in renal disease formula (MDRD) \< 30ml/mn/m²). * Previous failure of catheterization of the coronary sinus, or previous failure of left ventricular lead implantation. * Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks. * Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision). * Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate \< 1%.-

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Cardiac resynchronisation therapy

Contacts and locations

Locations

  • Bordeaux University Hospital

    Bordeaux, France

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, France

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Spain

  • Lille University Hospital

    Lille, France

  • Rennes University Hospital

    Rennes, France

  • Rouen University Hospital

    Rouen, France

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