Observational Recruiting
NCT07648329 on ClinicalTrials.gov
Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation
- Sponsor: Centre Hospitalier Universitaire Dijon Bourgogne
- Enrollment: 150 (Estimated)
- Study start: 2026-10-20 (Actual)
- Primary completion: 2029-10-01 (Estimated)
- Study completion: 2029-10-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief 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. 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.
Conditions
- Atrial Fibrillation (AF)
- Cardiac Arrhythmia
- Atrial Fibrillation Ablation
- BDNF
- Atrial Cardiomyopathy
Intervention / Treatment
- Biological: blood draw
- Procedure: CT scan
Primary Outcome Measures
-
First recurrence of AF between 3 and 12 months following an initial ablation for persistent AF
(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
Countries
France
Locations and Investigators
-
Chu Dijon Bourogne, Dijon, France (Recruiting)
- Charles GUENANCIA