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NCT Number: NCT07648329

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blood Draw

Biological

Measurement of circulating BDNF levels via blood sample

CT Scan

Procedure

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

Primary outcomes

  1. 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.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Charles GUENANCIA

CONTACT

[email protected]

03.80.29.56.23 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: METAPROFIL 2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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