Tests heart procedure effect on memory in people with mild cognitive impairment
Compares catheter ablation with drugs alone for irregular heartbeat in older adults with memory problems.
Key facts
- Who runs it
- Poitiers University Hospital
- Where
- Angers, Brest, Caen, Dijon, Grenoble, Marseille, Poitiers, and Saint-Denis, FranceSee the 8 sites
- Trial code
- Registry title
- EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 21 Apr 2023
- Expected to end
- Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Atrial fibrillation ablation + antiarrhythmic drugs
- Antiarrhythmic drug
- Record updated
- 23 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 60 to 80 with long-lasting (persistent) atrial fibrillation and mild memory and thinking problems who need heart rhythm control.
- Age
- 60 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Persistent atrial fibrillation with an indication for heart rhythm control and mild cognitive impairment (Montreal Cognitive Assessment score between 18 and 25 points). Very advanced atrial fibrillation is excluded.
- Earlier treatment
- People who had a previous atrial fibrillation ablation cannot join.
Main reasons for not taking part
- History of clinical stroke
- History or suspicion of a neurodegenerative disease such as Parkinson's or Alzheimer's disease, or of severe depression, bipolar disorder or schizophrenia
- Previous atrial fibrillation ablation
- Atrial fibrillation for more than 3 years, or a left atrial diameter >60 mm or volume > 48ml/m2
- Pregnant or breastfeeding women, or women who can have children and do not use effective contraception
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patient with history of previous atrial fibrillation ablation
- 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
- 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
- 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)
- Impossibility to perform the neuropsychological evaluation (communication problems such as hearing loss or aphasia, language barrier)
- Patient undergoing flutter ablation or atrial tachycardia ablation (not atrial fibrillation ablation)
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 80 years old?
Where in France
- CHU AngersAngers, FranceContact: Sophie Le PageTaking people
- University HospitalBrest, FranceContact: Jacques MansouratiTaking people
- University HospitalCaen, FranceContact: Pierre OllitraultTaking people
- University HospitalDijon, FranceContact: Charles GuenanciaTaking people
- Chu GrenobleGrenoble, FranceContact: Peggy JaconTaking people
- La TimoneMarseille, FranceContact: Baptiste MailleTaking people
- University HospitalPoitiers, FranceContact: Rodrigue GarciaTaking people
- Centre Cardiologique du NordSaint-Denis, FranceContact: Olivier PiotNot yet recruiting
About the trial
What the trial wants to find out
The goal of this clinical trial is to evaluate the effect of catheter ablation of persistent atrial fibrillation on cognitive function in patients with mild cognitive impairment. Participants will be randomized into antiarrhythmic drugs alone or atrial fibrillation ablation + antiarrhythmic drugs.
The 2 groups in the trial
- Atrial fibrillation + antiarrhythmic drugsTreatment being tested
The ablation can be done with different sources of energy (radiofrequency, cryoballoon or pulsed field ablation). Different sets of lesions can be performed but the cornerstone is pulmonary vein isolation which will be mandatory. Antiarrhythmic drugs management will be at the operator discretion. Some operators may stop antiarrhythmic drugs after atrial fibrillation ablation.
Treatment: Atrial fibrillation ablation + antiarrhythmic drugs
- Antiarrhythmic drugs aloneExisting treatment, for comparison
Antiarrhythmic drugs available available are amiodarone, flecainide, propafenone, sotalol. If not previously started, patients randomized to antiarrhythmic drugs arm should start antiarrhythmic drugs therapy within 1 week of randomization. Apart from these recommendations, antiarrhythmic drugs management will be at the operator discretion.
Treatment: Antiarrhythmic drug
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-
- Plain-language title
- Tests heart procedure effect on memory in people with mild cognitive impairmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05790707, who can take part
- Record updated
- 23 January 2026