Heart fix may shield brain: FALCON trial tests ablation for memory loss
NCT ID NCT05790707
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
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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
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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60 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHU Angers
RECRUITINGAngers, France
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CHU Grenoble
RECRUITINGGrenoble, France
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Centre Cardiologique du Nord
NOT_YET_RECRUITINGSaint-Denis, France
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La Timone
RECRUITINGMarseille, France
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University Hospital
RECRUITINGBrest, France
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University Hospital
RECRUITINGCaen, France
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University Hospital
RECRUITINGDijon, France
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University Hospital
RECRUITINGPoitiers, France
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Other studies related to the condition(s) this trial covers.
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- Extra vein ablation tested to keep persistent AFib from returning
- Can pool workouts plus brain games sharpen memory in aging veterans?