RecruitingNot ApplicableNCT05790707

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

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


Sponsor

Poitiers University Hospital

Enrollment

120 participants

Start Date

Apr 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether treating persistent atrial fibrillation (an irregular heart rhythm) with catheter ablation — a procedure that uses energy to correct abnormal electrical signals in the heart — can slow or improve mild cognitive decline. Both atrial fibrillation and mild cognitive impairment (MCI) are common in older adults, and researchers believe the two may be linked. **You may be eligible if...** - You are between 60 and 80 years old - You have persistent atrial fibrillation and your doctor recommends restoring normal heart rhythm - You have mild cognitive impairment (MCI) based on a standardized memory test score between 18 and 25 - You are covered by French national health insurance **You may NOT be eligible if...** - You have had a clinical stroke - You have been diagnosed with or suspected to have a neurodegenerative disease (like Alzheimer's or Parkinson's), severe depression, bipolar disorder, or schizophrenia - You have previously had atrial fibrillation ablation - You have significant hearing loss, language problems, or other barriers preventing neuropsychological testing - You have a contraindication to ablation or anticoagulation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAtrial fibrillation ablation + antiarrhythmic drugs

Atrial fibrillation ablation will be performed with endovascular catheters and will be done either with radiofrequency, cryoballoon or pulsed field ablation. Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

DRUGAntiarrhythmic drug

Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.


Locations(8)

CHU Angers

Angers, France

University Hospital

Brest, France

University Hospital

Caen, France

University Hospital

Dijon, France

CHU Grenoble

Grenoble, France

La Timone

Marseille, France

University Hospital

Poitiers, France

Centre Cardiologique du Nord

Saint-Denis, France

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NCT05790707


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