Effect of heart procedure on thinking skills in older adults with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess how catheter ablation of persistent atrial fibrillation impacts cognitive function in individuals aged 60 to 85 with mild cognitive impairment. Participants will be randomly assigned to receive either antiarrhythmic drugs alone or a combination of atrial fibrillation ablation and antiarrhythmic drugs. The study will evaluate cognitive changes using standardized assessments to determine the effectiveness of the intervention. The goal is to provide insights into the relationship between heart rhythm control and cognitive health.

Why it matters

Who can join: the full rules

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)

Where it's running

• CHU Angers
  Angers, France Recruiting
• University Hospital
  Brest, France Recruiting
• University Hospital
  Caen, France Recruiting
• University Hospital
  Dijon, France Recruiting
• CHU Grenoble
  Grenoble, France Recruiting
• La Timone
  Marseille, France Recruiting

Study contacts

• Study coordinator: Rodrigue Garcia
• Email: rodrigue.garcia@chu-poitiers.fr
• Phone: 549443729

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.