Cardiac Ablation Clinical Trials

Clinical trials related to Cardiac Ablation Procedure

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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
University Hospital
RECRUITING
Brest
University Hospital
RECRUITING
Caen
University Hospital
RECRUITING
Dijon
CHU Grenoble
RECRUITING
Grenoble
La Timone
RECRUITING
Marseille
University Hospital
RECRUITING
Poitiers
Centre Cardiologique du Nord
NOT_YET_RECRUITING
Saint-denis
Contact Information
Primary
Rodrigue Garcia
rodrigue.garcia@chu-poitiers.fr
549443729
Time Frame
Start Date: 2023-04-21
Estimated Completion Date: 2027-07
Participants
Target number of participants: 120
Treatments
Experimental: Atrial fibrillation + antiarrhythmic drugs
The ablation can be done with different sources of energy (radiofrequency, cryoballoon or pulsed field ablation). Different sets of lesions can be performed but the cornerstone is pulmonary vein isolation which will be mandatory.~Antiarrhythmic drugs management will be at the operator discretion. Some operators may stop antiarrhythmic drugs after atrial fibrillation ablation.
Active_comparator: Antiarrhythmic drugs alone
Antiarrhythmic drugs available available are amiodarone, flecainide, propafenone, sotalol.~If not previously started, patients randomized to antiarrhythmic drugs arm should start antiarrhythmic drugs therapy within 1 week of randomization.~Apart from these recommendations, antiarrhythmic drugs management will be at the operator discretion.
Related Therapeutic Areas
Sponsors
Leads: Poitiers University Hospital

This content was sourced from clinicaltrials.gov