NCT05790707 · RECRUITING
EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment
This trial tests whether a heart procedure called catheter ablation, plus heart rhythm medication, protects thinking and memory better than medication alone. Participants have persistent atrial fibrillation (an irregular heartbeat) and mild cognitive impairment. Phase is not applicable, which is typical for procedure studies rather than new-drug trials. It is not proven or approved for this purpose.
You may qualify if
- 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
You're excluded if
- 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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-23