NCT07648329

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Outcome Measures

Primary Outcomes (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

    Between 3 and 12 months after the first AF ablation.

Study Arms (1)

Patients scheduled for ablation of persistent atrial fibrillation

Biological: blood drawProcedure: CT scan

Interventions

blood drawBIOLOGICAL

Measurement of circulating BDNF levels via blood sample

Patients scheduled for ablation of persistent atrial fibrillation
CT scanPROCEDURE

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

Patients scheduled for ablation of persistent atrial fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 15, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations