Effect of heart procedure on thinking skills in older adults with mild cognitive impairment
EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-
This study is testing if a heart procedure combined with medication can help improve thinking skills in older adults with mild cognitive impairment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 8 sites (Angers and 7 other locations) |
| Trial ID | NCT05790707 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 to 85 with persistent atrial fibrillation and mild cognitive impairment.
Not a fit: Patients with a history of clinical stroke or neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cognitive function in patients with mild cognitive impairment by addressing underlying atrial fibrillation.
How similar studies have performed: While there is limited data on this specific approach, similar studies have suggested potential cognitive benefits from managing atrial fibrillation, making this a promising area of investigation.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Angers and 7 other locations
- 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)
- University Hospital — Poitiers, France (Recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Rodrigue Garcia
- Email: rodrigue.garcia@chu-poitiers.fr
- Phone: 549443729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.