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Heart procedure may offer stroke prevention for patients who Can't take blood thinners

NCT ID NCT03111654

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a procedure to close the left atrial appendage—a small pouch in the heart where clots often form—in 58 patients with atrial fibrillation who had a prior brain bleed and cannot take standard blood thinners. The goal was to see if this approach could reduce the risk of future strokes and other vascular events. Researchers tracked outcomes like stroke, bleeding, and functional status over time.

What this could mean

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

Active substance
percutaneous left atrial appendage closure (a procedure to seal off a small pouch in the heart)
What this could lead to
If successful, this approach could offer a safe way to prevent strokes in people with atrial fibrillation who cannot use standard blood thinners because of a past brain bleed.
What could go wrong
This is a small pilot study with only 58 participants and no comparison group, so results may not apply broadly. The procedure itself carries risks like bleeding or infection.

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

58 people

The number who actually took part.

Started

Jul 2016

Finished

Oct 2017

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: * Patients aged 18 years or older * Affiliation to a social security scheme * Non-valvular, paroxysmal, persistent or permanent atrial fibrillation * CHA2DS2-VASc greater than or equal to 2 * History of intracranial haemorrhage: Intra-parenchymal hematoma, subacute or chronic subcutaneous hematoma And * Patients having benefited from the percutaneous closure of the auricle at the University Hospital of Amiens * Either patient admitted to the CHU of Amiens in neurology, neurosurgery or geriatrics for intracranial haemorrhage, who received standard medical treatment for the comparison group. Exclusion Criteria: * CHADS2VASC2 less than 2 * Extradural hematoma * Arachnoidal haemorrhage by rupture of aneurysm * Haemorrhagic transformation of ischemic stroke * Other indication of anticoagulation than FA * Modified Rankin scale greater than 4 following intracranial hemorrhage. * Early death, in the month following the onset of intracranial hemorrhage.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation intracerebral hemorrhage Intracranial Hemorrhages stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation Intracranial hemorrhages

Contacts and locations

Locations

  • CHU Amiens Picardie

    Amiens, Picardie, 80054, France

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