EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals with Mild Cognitive Impairment

Launched by POITIERS UNIVERSITY HOSPITAL · Mar 16, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how a procedure called catheter ablation, which helps treat a heart condition known as persistent atrial fibrillation, affects thinking and memory in older adults who have mild cognitive impairment. Participants will be randomly assigned to receive either antiarrhythmic medications alone or a combination of the catheter ablation procedure and these medications. The goal is to see if treating the heart condition can also improve cognitive function.

To be eligible for this study, participants must be between 60 and 85 years old, have persistent atrial fibrillation, and score between 18 and 25 on a cognitive test, indicating mild cognitive impairment. Interested individuals will need to provide written consent and have health insurance coverage in France. It's important to note that certain medical histories or conditions may exclude someone from participating, such as a previous stroke or severe depression. Participants can expect to be closely monitored throughout the study, and their cognitive function will be assessed to evaluate any changes resulting from the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 60 to 85 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)