Predictive Properties of Myocardial Fibrosis Biomarkers on the Outcome of Atrial Fibrillation Ablation

Phase

N/A

Condition

Scar Tissue

Chest Pain

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT05179902

RNI 2021 MASSOULIE

2021-A02091-40

Ages > 18
All Genders

Study Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia. As an independent predictor of cardiovascular mortality, particularly for stroke, its management is a real public health issue. AF is associated with diabetes, obesity, hypertension, heart failure and, occasionally, hyperthyroidism. Atrial fibrosis is one of the major players in the genesis and maintenance of AF. It has a strong impact on rhythmic prognosis and treatment success.

Currently the AF ablation is the treatment recommended by the European Society of Cardiology (ESC) and by the American Society of Cardiology. The rate of AF recurrence is variable according to the patient characteristics and remains unfortunately today difficult to predict.

Abnormal concentrations of circulating biomarkers reflecting the underlying pathophysiologic mechanisms of myocardial fibrosis could help to identify patients at higher risk of developing AF and/or AF recurrence after ablation. Thus, the development of simple, reliable and valid biological tests of atrial fibrosis would allow the clinicians i) to estimate the potential success of AF ablation; ii) to predict AF recurrence; iv) and to propose a AF personalized therapeutic approach.

The main objective of PROFIB-AF study is to identify, among biological markers (ICTP, PICP, PIIINP, sRAGE, AGE, Galectin 3, sSt2, microRNAs) of myocardial fibrosis, those which can predict the recurrence risk after AF ablation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult patient, male or female, eligible for an AF ablation procedure according to therecommendations (European Society of Cardiology 2020 and American Society ofCardiology 2014), either for symptomatic paroxysmal AF refractory to anti-arrhythmictreatments (or in first intention according to patient preference), or for symptomaticpersistent AF.
Able to give their non-opposition to participate in the research.
Affiliation to a social security regime.

Exclusion

Exclusion Criteria:

Any pro-fibrotic phenomenon that may interfere with the interpretation of the results,i.e. severe valvular heart disease, amyloid heart disease, dilated cardiomyopathy ofnon-rhythmic origin, hypertrophic cardiomyopathy, severe ischaemic heart disease (laterevascularisation, LV dysfunction, disturbed kinetics), COPD > stage 2, pulmonaryfibrosis, renal failure > stage 3A, hepatic cirrhosis, hepatocellular failure, recentinvasive surgery < 3 months
Life expectancy less than 1 year
Pregnant or breastfeeding women
Patients of legal age under protective supervision (guardianship, trusteeship)
Refusal to participate

Study Design

January 20, 2022

January 31, 2025

Study Description

Patients prone to AF ablation and do not object to participate at PROFIB-AF study will be offered, in parallel of their conventional care, blood samples the day of AF ablation by femoral and sinusal punctures and 12 months after ablation by venipuncture for the biomarkers analysis.

As part of their traditional care, these patients will benefit several exams beforeAF ablation (MRI, clinical examination ECG, echocardiography, routine biological analyzes), and four follow-up visits after AF ablation (at 3, 6, 9 and 12 months post-ablation) to evaluate AF recurrence, occurrence of MACE and heart failure signs.

Connect with a study center

CHU clermont-ferrand
Clermont-Ferrand,
France
Active - Recruiting

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