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Atrial Fibrillation (AF)METAPROFIL 2NCT07648329

Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation

An observational study of Atrial Fibrillation (AF) and Cardiac Arrhythmia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

trial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and its prevalence continues to rise. AF is associated with serious complications, including embolic strokes, heart failure, and mortality. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
blood draw and CT scan
Type of treatment
Surgery or procedure
How many people
150 participants
Where
1 siteFrance
Study dates
20 Oct 2026to Oct 2029
Phase
Observational
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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients scheduled to undergo their first ablation procedure for persistent atrial fibrillation at the Dijon Bourgogne University Hospital.

Who may be able to join

  • Participants who have provided written consent
  • Patients aged 18 years or older.
  • Patients scheduled to undergo their first ablation procedure for persistent atrial fibrillation at the Dijon Bourgogne University Hospital

Who cannot join

  • A person who is not enrolled in or eligible for a social security program
  • A person subject to a legal protective measure (guardianship, conservatorship)
  • Person subject to a judicial safeguard measure
  • Pregnant or breastfeeding woman
  • Adult who is legally incapacitated or unable to give consent
  • Ablation of paroxysmal AF with or without electroanatomical mapping

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Chu Dijon Bourogne

    Dijon, 21000

    Charles GUENANCIA, 03.80.29.56.23 ext. +33, charles.guenancia@chu-dijon.fr

    Recruiting

Other trials in France

About this study

trial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and its prevalence continues to rise. AF is associated with serious complications, including embolic strokes, heart failure, and mortality. Characterized by rapid, irregular, and weakened contractions of the atria, AF is considered one of the "visible" electrophysiological manifestations of a broader condition known as atrial cardiomyopathy (ACM). Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, predisposes to thrombus formation. Once dislodged from the atrial cavity and migrating to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for ACI/AF are metabolic syndrome and aging. CMA is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, we aim to address this challenge by approaching CMA through one of its complications: persistent atrial fibrillation. Indeed, CMA can be assessed using electroanatomical mapping during atrial fibrillation ablation (AFA) procedures. During radiofrequency ablation of AF, electroanatomical mapping of the left atrium is performed to measure left atrial voltage, which serves as an indirect marker of the presence of atrial fibrosis, strongly associated with CMA. Other parameters relevant to the identification of CMA can be assessed during this procedure, such as conduction velocities and specific electrographic characteristics.

We plan to include 150 patients undergoing ablation for persistent atrial fibrillation at the Dijon Bourgogne University Hospital and to correlate circulating levels of BDNF (brain-derived neurotrophic factor) with electroanatomical mapping data of the left atrium. The electrical remodeling of the left atrium, including low-voltage areas and conduction velocity, as well as left atrial morphology assessed by pre-procedural cardiac computed tomography using the ADAS3 Galgo LA Module software, will be correlated with BDNF levels. Blood samples for BDNF assessment will be collected before or at the start of the ablation procedure, prior to any catheter insertion into the vessels.

While investigating the association between BDNF levels and CMA characteristics during AF ablation, thereby confirming the pathophysiological relationship with atrial remodeling, our objective is also to evaluate the prognostic role of BDNF levels in clinical and rhythm outcomes following AF ablation. Thus, we will compare changes in BDNF levels after AF ablation at one-year follow-up, correlating them with the evolution of CMA-based on left atrial parameters assessed by echocardiography or cardiac computed tomography-autonomic nervous system balance and heart rhythm obtained via Holter monitoring, as well as clinical outcomes.

Being tested
blood draw, CT scan
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood drawBiological

    Measurement of circulating BDNF levels via blood sample

  • CT scanProcedure or surgery

    Performing a cardiac CT scan to assess changes in atrial cardiomyopathy parameters

Study groups in NCT07648329
Study groupRoleWhat they receive
Patients scheduled for ablation of persistent atrial fibrillationNot described
Receives: Biological: blood draw; Procedure: CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First recurrence of AF between 3 and 12 months following an initial ablation for persistent AF

    First recurrence of AF between 3 and 12 months following an initial ablation for persistent AF, defined as the first documented recurrence beyond the 3-month post-ablation blanking period, in accordance with the 2020 ESC and 2022 EHRA guidelines. The diagnosis is based on: (1) documentation of AF on a 12-lead ECG during an outpatient visit or hospitalization, or (2) documentation on a Holter ECG ≥ 24 hours performed routinely or for clinical reasons, or (3) any ambulatory rhythm recording documenting AF ≥ 30 seconds

    Measured: Between 3 and 12 months after the first AF ablation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start20 Oct 2026
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07648329
Sponsor's protocol ID
GUENANCIA ANR 2024-1
Acronym
METAPROFIL 2
Status last verified
Oct 2026
First submitted
10 Jun 2026
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF) and Cardiac Arrhythmia, run by Centre Hospitalier Universitaire Dijon at 1 site 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 3 inclusion and 6 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Charles GUENANCIA (03.80.29.56.23 ext. +33, charles.guenancia@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First recurrence of AF between 3 and 12 months following an initial ablation for persistent AF (time frame: Between 3 and 12 months after the first AF ablation.). 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 26 Oct 2026.

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