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Heart closure device put to the test: does it preserve heart function?

NCT ID NCT05150366

Knowledge-focused Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study examines whether closing the left atrial appendage with a device called AMULET changes how well the heart relaxes. It includes 100 adults with atrial fibrillation who are at high risk for stroke but cannot take blood thinners. Researchers measure heart function using ultrasound before and after the procedure to see if it stays the same.

What this could mean

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

Active substance
percutaneous closure of the left atrial appendage using the St Jude AMULET device
What this could lead to
If successful, this study could show that left atrial closure does not harm heart function, supporting its use as a safe alternative to blood thinners.
What could go wrong
This is a small, early observational study focused on a specific measurement, not on long-term outcomes. The results may not apply to all patients.

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

100 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2025

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: * Man or woman over 18 years-old * Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants * Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device * Patient in sinus rhythm * Subject affiliated or beneficiary of a social security scheme * Patient having signed the informed consent Exclusion Criteria: * Patient participating in another clinical study * Patient in permanent ACFA * Patient with a mitral prosthesis (biological or mechanical), * Patient with a history of mitral annuloplasty * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; * Pregnant, breastfeeding or parturient woman; * Patient hospitalized without consent.

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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.

Left atrial closure Tissue doppler

Contacts and locations

Locations

  • Hôpital Privé Le Bois

    Lille, 59000, France

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