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Heart fix may shield brain: FALCON trial tests ablation for memory loss

NCT ID NCT05790707

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a heart procedure called catheter ablation can slow down memory loss in people with mild cognitive impairment who also have a common heart rhythm problem called atrial fibrillation. 120 participants will be randomly assigned to get either the ablation plus heart-rhythm drugs, or the drugs alone. The main goal is to see if the ablation group has better scores on a memory and thinking test after 6 months.

What this could mean

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

Active substance
catheter ablation (a procedure using heat or cold to destroy heart tissue causing irregular rhythm) plus antiarrhythmic drugs
What this could lead to
If it works, this could point toward a way to preserve memory and thinking in people with both atrial fibrillation and mild cognitive impairment.
What could go wrong
This is a small, early-stage study (120 people) and the main outcome is a questionnaire score, not a hard endpoint. The procedure carries risks like bleeding, infection, or heart damage, and the cognitive benefit is uncertain.

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

About 120 people

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

Started

Apr 2023

Expected to finish

Jul 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.

Ages

60 to 80 years

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 60 to 80 years * Persistent atrial fibrillation * Patients with an indication for cardiac rhythm control. * Montreal Cognitive Assessment score between 18 and 25 points corresponding to mild cognitive impairment * Free subject, not under temporary or permanent guardianship and not subject to subordination * Subject understanding and accepting the constraints of the study * Patient covered by French national health insurance or benefiting from it through a third party * Subject has given written consent to the study after having received clear and complete information Exclusion Criteria: * Impossibility to perform the neuropsychological evaluation (communication problems such as hearing loss or aphasia, language barrier) * History of clinical stroke * Presence of a bruit at carotid auscultation or history of severe carotid stenosis * History or suspicion of neurodegenerative disease (Parkinson's disease, Alzheimer's disease, Huntington's disease and amyotrophic lateral sclerosis...), bipolar disorder, schizophrenia, severe depression or amyloidosis * Patient with history of previous atrial fibrillation ablation * Patient undergoing flutter ablation or atrial tachycardia ablation (not atrial fibrillation ablation) * Contraindication to atrial fibrillation ablation (intracardiac thrombus, severe pulmonary hypertension, mechanical mitral valve prosthesis or contraindication to anticoagulation,…) * Contraindication to antiarrhythmic drugs, or to implantable cardiac monitor * Patient with very advanced persistent atrial fibrillation, i.e., for more than 3 years or with a left atrial diameter \>60 mm in parasternal long axis section or a left atrial volume \> 48ml/m2 in echocardiography * Subject with a life expectancy of less than 24 months at study enrolment * Inability to consent * Persons benefiting from a reinforced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations * Pregnant or breastfeeding women, women at age to procreate and not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    8 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

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Grenoble

    RECRUITING

    Grenoble, France

  • Centre Cardiologique du Nord

    NOT_YET_RECRUITING

    Saint-Denis, France

  • La Timone

    RECRUITING

    Marseille, France

  • University Hospital

    RECRUITING

    Brest, France

  • University Hospital

    RECRUITING

    Caen, France

  • University Hospital

    RECRUITING

    Dijon, France

  • University Hospital

    RECRUITING

    Poitiers, France

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