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New study aims to find safest route for pacemaker implants

NCT ID NCT07273929

Disease control Sponsor: Hospices Civils de Lyon 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares three methods for inserting the wires (leads) of pacemakers or defibrillators during first-time implantation. The three techniques are: cutting down to a vein in the shoulder, using ultrasound to guide a needle through the skin, or using a special ultrasound probe placed inside the incision. The goal is to see which method is most successful and has the fewest complications. The trial will involve 900 adults across multiple centers.

What this could mean

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

What this could lead to
If successful, this trial could establish a standard, safer method for implanting pacemakers and defibrillators, reducing complications like collapsed lung or bleeding.
What could go wrong
This is a procedure comparison, not a new treatment. Even if one technique proves better, it may not be suitable for all patients or settings.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 900 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 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: * Age ≥ 18 years * First implantation of a pacemaker or defibrillator (single or double chamber) or implantation of a lead in the left branch area in the case of a venticular lead. * Informed consent signed by the patient Exclusion Criteria: * Implantation of an intra-cardiac triple-chamber electronic device (cardiac resynchronisation) * Prior impossibility of venous access * Pregnant, parturient or breast-feeding women * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care * Persons admitted to a health or social establishment for purposes other than research * Adults under legal protection (guardianship, curatorship) * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme * Patients participating in other research that may interfere with this study

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As listed by the trial registrant

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

Primary implantation of an intracardiac electronic device indication

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Annexy-Genevois, site Annecy

    Metz, 74000, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000, France

  • CHU de Saint Etienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42800, France

  • Hôpital F. MITTERRAND

    Dijon, 21000, France

  • Hôpital privé Jacques Cartier

    Massy, 91300, France

  • Lyon-Croix Rousse

    Lyon, 69004, France

  • Lyon-Louis Pradel

    Lyon, 69500, France