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

Recruiting

• Conditions: AF Ablation (ECS recommendation2020&ACS2014) Either for Paroxysmal AF Unresponsive to Anti-arrhythmic Treatment Either for Persisting Symptomatic AF; Women and Men Over 18 Years Old; Able to Give His Non Opposition to Participate to the Study

• Registration Number: NCT05179902
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-06
• Study Start: 2022-01-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

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

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 of non-rhythmic origin, hypertrophic cardiomyopathy, severe ischaemic heart disease (late revascularisation, LV dysfunction, disturbed kinetics), COPD > stage 2, pulmonary fibrosis, renal failure > stage 3A, hepatic cirrhosis, hepatocellular failure, recent invasive 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of an atrial fibrillation recurrence	AGE at 12 months (in ng/mL)	Biological markers profil

Secondary Outcome Measures

Name	Time	Method
Dominant frequency of AF	Congestive signs at 12 months (yes, left, right, global; or not)	Clinical exam
Rate of fibrosis of the left atrium	Endocardial left atria low voltage area (<0.5mV) in sinus rhythm (in %)	Voltage mapping

Trial Locations

Locations (1)

CHU clermont-ferrand; 🇫🇷 Clermont-Ferrand, France