Mild Cognitive ImpairmentNCT05790707
EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment
A study testing Atrial fibrillation ablation + antiarrhythmic drugs and Antiarrhythmic drug in people with Mild Cognitive Impairment and Persistent Atrial Fibrillation, run by Poitiers University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment, Persistent Atrial Fibrillation
- What is being tested?
- Atrial fibrillation ablation + antiarrhythmic drugs and Antiarrhythmic drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesFrance
- Study dates
- 21 Apr 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU Angers
Angers
Sophie Le Page, +332 41 35 36 37, sophie.lepage@chu-angers.fr
- Recruiting
University Hospital
Brest
Jacques Mansourati
- Recruiting
University Hospital
Caen
Pierre Ollitrault
- Recruiting
University Hospital
Dijon
Charles Guenancia
- Recruiting
CHU Grenoble
Grenoble
Peggy Jacon, +334 76 76 75 75
- Recruiting
La Timone
Marseille
Baptiste Maille, +33491 38 00 00, baptiste.maille@aphm.fr
- Recruiting
University Hospital
Poitiers
Rodrigue Garcia
- Not yet recruiting
Centre Cardiologique du Nord
Saint-Denis
Olivier Piot
About this study
Official title: EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-
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.
- Being tested
- Atrial fibrillation ablation + antiarrhythmic drugs, Antiarrhythmic drug
- Medical subject headings
- Cognitive Dysfunction, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablation + antiarrhythmic drugsProcedure or surgery
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.
Antiarrhythmic drugDrug
Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation + antiarrhythmic drugs | Experimental | 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. Receives: Procedure: Atrial fibrillation ablation + antiarrhythmic drugs |
| Antiarrhythmic drugs alone | Active comparator | 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. Receives: Drug: Antiarrhythmic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessmentquestionnaire score evolution 6 months
To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 6 months after randomization (M6), compared with "antiarrhythmic drugs alone" in patients with persistent atrial fibrillation associated with mild cognitive impairment. The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.
Measured: baseline (randomization) and 6 months after randomization
Secondary outcomes (6)
Baseline characteristics associated with Montreal Cognitive Assessment score improvement
To define the baseline characteristics associated with Montreal Cognitive Assessment improvement between randomization (M0) and 6 months after randomization (M6) in patients with mild cognitive impairment and persistent atrial fibrillation undergoing atrial fibrillation ablation. The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.
Measured: baseline (randomization) and 6 months after randomization
Changes in different types of cognitive functions
To assess changes in different cognitive functions measured by a comprehensive neurocognitive assessment between randomization (M0) and 6 months after randomization (M6). The assessed tests are : Free recall/indexed recall 16, WAIS IV "digit memory" subtest, Rapid Frontal Efficiency Battery (BREF) score, Trail Making Test (TMT- GREFEX version), Verbal fluency (GREFEX version) categorical (animals) and literal (letter P), Oral naming of the BETL (Battery for the Evaluation of Language Disorders), STROOP test (GREFEX version), Rey figure, Processing speed index from the WAIS IV.
Measured: baseline (randomization) and 6 months after randomization
Montreal Cognitive Assessment questionnaire score evolution 12 months
To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 12 months after randomization (M12), compared with "antiarrhythmic drugs alone". The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.
Measured: baseline (randomization) and 12 months after randomization
Association between atrial fibrillation burden and cognitive function
To evaluate the association between atrial fibrillation burden and cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 12 months after randomization (M12). The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.
Measured: baseline (randomization) and 12 months after randomization
Quality of life Short Form Survey (SF-12)
To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on quality of life assessed by the change at the 12-Item Short Form Survey (SF-12) between randomization (M0), 6 and 12 months after randomization (M6 and M12), compared with "antiarrhythmic drugs alone". Score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: baseline (randomization), 6 and 12 months after randomization
Quality of life QOL-AD
To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on quality of life assessed by the change at the Quality of life in Alzheimer's Disease (QOL-AD) questionnaire scores between randomization (M0), 6 and 12 months after randomization (M6 and M12), compared with "antiarrhythmic drugs alone". Score ranges from 13 to 52. The higher the score, the better quality of life the participant has.
Measured: baseline (randomization), 6 and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start21 Apr 2023
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790707
- Sponsor's protocol ID
- FALCON study
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-
- ClinicalTrials.gov ID
- NCT05790707
- Acronym / sponsor ID
- FALCON study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation + antiarrhythmic drugs | Experimental | Procedure: Atrial fibrillation ablation + antiarrhythmic drugsThe 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. |
| Antiarrhythmic drugs alone | Active comparator | Drug: Antiarrhythmic drugAntiarrhythmic 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial fibrillation ablation + antiarrhythmic drugsAtrial 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. | Procedure or surgery | Atrial fibrillation + antiarrhythmic drugs |
| Antiarrhythmic drugAmiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed. | Drug | Antiarrhythmic drugs alone |
Primary outcome
Montreal Cognitive Assessmentquestionnaire score evolution 6 months
Time frame: baseline (randomization) and 6 months after randomization
To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 6 months after randomization (M6), compared with "antiarrhythmic drugs alone" in patients with persistent atrial fibrillation associated with mild cognitive impairment. The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.
6 secondary outcomes
Baseline characteristics associated with Montreal Cognitive Assessment score improvement
Time frame: baseline (randomization) and 6 months after randomization
Changes in different types of cognitive functions
Time frame: baseline (randomization) and 6 months after randomization
Montreal Cognitive Assessment questionnaire score evolution 12 months
Time frame: baseline (randomization) and 12 months after randomization
Association between atrial fibrillation burden and cognitive function
Time frame: baseline (randomization) and 12 months after randomization
Quality of life Short Form Survey (SF-12)
Time frame: baseline (randomization), 6 and 12 months after randomization
Quality of life QOL-AD
Time frame: baseline (randomization), 6 and 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial fibrillation ablation + antiarrhythmic drugs and Antiarrhythmic drug in people with Mild Cognitive Impairment and Persistent Atrial Fibrillation, run by Poitiers University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigue Garcia (549443729 ext. +33, rodrigue.garcia@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessmentquestionnaire score evolution 6 months (time frame: baseline (randomization) and 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.