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ClinicalTrials.gov ID

NCT05790707

Lead Sponsor

Poitiers University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Jan 23, 2026Actual

Start Date

Apr 21, 2023Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jul 2027Estimated

Official Title

EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-

Brief Summary

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.

• Mild Cognitive Impairment
• Persistent Atrial Fibrillation

• Atrial fibrillation ablation + antiarrhythmic drugs
• Antiarrhythmic drug

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Poitiers University HospitalOTHER

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baptiste.maille@aphm.fr+33491 38 00 00