NCT05790707Recruiting
EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment
EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 5 Feb 2023
- Start date
- 21 Apr 2023
- Primary completion date
- Jan 2027
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05790707
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 21 Apr 2023 to the primary completion date, Jan 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with history of previous atrial fibrillation ablation
Other illness
- 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
Age
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 60 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| University Hospital Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| University Hospital Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| University Hospital Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Chu Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| La Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| University Hospital Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.