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New heart implant aims to prevent strokes without blood thinners

NCT ID NCT06465459

Disease control Sponsor: French Cardiology Society 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called LambrE that is implanted in the heart to close off a small pouch (the left atrial appendage) where blood clots often form in people with atrial fibrillation. The goal is to prevent strokes in patients who cannot take blood thinners due to bleeding risks. The study will follow 220 participants to see how well the device works and how safe it is.

What this could mean

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

Active substance
LAMBRE device (a small implant placed in the heart to close off the left atrial appendage)
What this could lead to
If successful, this device could offer a safe alternative to blood thinners for preventing strokes in people with atrial fibrillation who cannot take anticoagulant medication.
What could go wrong
This is a post-marketing study, not a randomized trial, so results may not prove superiority over other treatments. There is a risk of device migration or other complications, and the study is relatively small (220 participants).

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.

Participants

About 220 people

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

Started

Jun 2024

Expected to finish

Dec 2027

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.

Who is studied

Patients will be included in cardiology departments participating in the study. Non-valvular atrial fibrillation patients at high cardio-embolic risk, contraindicated to anticoagulants, scheduled for percutaneous left atrial closure with implantation of the Lambre device will be included in the protocol and monitored as part of their care by the centers that performed the procedure.

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: * Patient requiring a left atrial exclusion procedure according to the recommendations by the CNEDiMTS and HAS using the LAMBRE device * Age ≥18 years * Patient has been informed of the nature of the study and agrees to participate Exclusion Criteria: * Minor patient * Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

How to take part

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

  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

    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

  • Hôpital Cardiologique de Haut Lévêque

    RECRUITING

    Pessac, 33600, France

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