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

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of an atrial fibrillation recurrence | ECG 12 lead profile | Any AF episode >30 seconds at pre-ablation (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | ECG 12 lead profile | Any AF episode >30 seconds at 3 months (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | ECG 12 lead profile | Any AF episode >30 seconds at 6 months (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | ECG 12 lead profile | Any AF episode >30 seconds at 12 months (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | Holter ECG | Any AF episode >30 seconds at pre-ablation (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | Holter ECG | Any AF episode >30 seconds at 3 months (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | Holter ECG | Any AF episode >30 seconds at 6 months (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | Holter ECG | Any AF episode >30 seconds at 12 months (yes or no) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | PIIINP at pre-ablation (in ng/mL | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | PIIINP at 12 months (in ng/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | ICTP at pre-ablation (in ng/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | ICTP at 12 months (in ng/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | PICP at pre-ablation (in ng/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | PICP at 12 months (in ng/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | sRAGE at pre-ablation (in pg/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | sRAGE at 12 months (in pg/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | AGE at pre-ablation (in ng/mL) | 
| Occurrence of an atrial fibrillation recurrence | Biological markers profil | AGE at 12 months (in ng/mL) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fibrosis of the left atrium | IRM profile | Degree of left atrial fibrosis on MRI at the inclusion (pre-ablation; in %) | 
| Rate of fibrosis of the left atrium | Voltage mapping | Endocardial left atria low voltage area (<0.5mV) in sinus rhythm (in %) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave frequency at the inclusion (pre-ablation; in ms) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave frequency at 3 months (in ms) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave frequency at 6 months (in ms) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave frequency at 12 months (in ms) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave amplitude at the inclusion (pre-ablation; in mv) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave amplitude at 3 months (in mv) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave amplitude at 6 months (in mv) | 
| Dominant frequency of AF | ECG 12 lead profil | F wave amplitude at 12 months (in mv) | 
| Dominant frequency of AF | ECG 12 lead profil | AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent) | 
| Dominant frequency of AF | ECG 12 lead profil | AF characteristics at 3 months (paroxysmal, persistent) | 
| Dominant frequency of AF | ECG 12 lead profil | AF characteristics at 6 months (paroxysmal, persistent) | 
| Dominant frequency of AF | ECG 12 lead profil | AF characteristics at 12 months (paroxysmal, persistent) | 
| Dominant frequency of AF | ECG 12 lead profil | AF duration at the inclusion (pre-ablation, in ms) | 
| Dominant frequency of AF | ECG 12 lead profil | AF duration at 3 months (in ms) | 
| Dominant frequency of AF | ECG 12 lead profil | AF duration at 6 months (in ms) | 
| Dominant frequency of AF | ECG 12 lead profil | AF duration at 12 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | F wave frequency at the inclusion (pre-ablation; in ms) | 
| Dominant frequency of AF | Holter ECG profil | F wave frequency at 3 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | F wave frequency at 6 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | F wave frequency at 9 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | F wave frequency at 12 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | F wave amplitude at the inclusion (pre-ablation; in mV) | 
| Dominant frequency of AF | Holter ECG profil | F wave amplitude at 3 months (in mV) | 
| Dominant frequency of AF | Holter ECG profil | F wave frequency at 6 months (in mV) | 
| Dominant frequency of AF | Holter ECG profil | F wave amplitude at 9 months (in mV) | 
| Dominant frequency of AF | Holter ECG profil | F wave amplitude at 12 months (in mV) | 
| Dominant frequency of AF | Holter ECG profil | AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent) | 
| Dominant frequency of AF | Holter ECG profil | AF characteristics at 3 months (paroxysmal, persistent) | 
| Dominant frequency of AF | Holter ECG profil | AF characteristics at 6 months (paroxysmal, persistent) | 
| Dominant frequency of AF | Holter ECG profil | AF characteristics at 9 months (paroxysmal, persistent) | 
| Dominant frequency of AF | Holter ECG profil | AF characteristics at 12 months (paroxysmal, persistent) | 
| Dominant frequency of AF | Holter ECG profil | AF duration at the inclusion (pre-ablation; in ms) | 
| Dominant frequency of AF | Holter ECG profil | AF duration at 3 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | AF duration at 6 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | AF duration at 9 months (in ms) | 
| Dominant frequency of AF | Holter ECG profil | AF duration at 12 months (in ms) | 
| Dominant frequency of AF | Echocardiography | Left atria volume at pre-ablation (mL) | 
| Dominant frequency of AF | Echocardiography | Left atria volume at 12 months (mL) | 
| Dominant frequency of AF | Echocardiography | Indexed left atria volume at pre-ablation (mL) | 
| Dominant frequency of AF | Echocardiography | Indexed left atria volume at 12 months (mL) | 
| Dominant frequency of AF | Echocardiography | LVEF at the inclusion (pre-ablation; %) | 
| Dominant frequency of AF | Echocardiography | LVEF at 12 months (%) | 
| Dominant frequency of AF | Biological profil | Hemoglobin at pre-ablation (in g/dL) | 
| Dominant frequency of AF | Biological profil | Hemoglobin at 12 months (in g/dL) | 
| Dominant frequency of AF | Biological profil | HbA1c at pre-ablation (in %) | 
| Dominant frequency of AF | Biological profil | HbA1c at 12 months (in %) | 
| Dominant frequency of AF | Biological profil | Kalemia at pre-ablation (in mmol/L) | 
| Dominant frequency of AF | Biological profil | Kalemia at 12 months (in mmol/L) | 
| Dominant frequency of AF | Biological profil | Natremia at pre-ablation (in mmol/L) | 
| Dominant frequency of AF | Biological profil | Natremia at 12 months (in mmol/L) | 
| Dominant frequency of AF | Biological profil | Glycemia at pre-ablation (in mmol/L) | 
| Dominant frequency of AF | Biological profil | Glycemia at 12 months (in mmol/L) | 
| Dominant frequency of AF | Biological profil | Total bilirubin at pre-ablation (in µmol/L) | 
| Dominant frequency of AF | Biological profil | Total bilirubin at 12 months (in µmol/L) | 
| Dominant frequency of AF | Biological profil | ASAT at pre-ablation (in U/L) | 
| Dominant frequency of AF | Biological profil | ASAT at 12 months (in U/L) | 
| Dominant frequency of AF | Biological profil | ALAT at pre-ablation (in U/L) | 
| Dominant frequency of AF | Biological profil | ALAT at 12 months (in U/L) | 
| Dominant frequency of AF | Biological profil | GGT at pre-ablation (in U/L) | 
| Dominant frequency of AF | Biological profil | GGT at 12 months (in U/L) | 
| Dominant frequency of AF | Biological profil | PAL at pre-ablation (in U/L) | 
| Dominant frequency of AF | Biological profil | PAL at 12 months (in U/L) | 
| Dominant frequency of AF | Biological profil | LDH at pre-ablation (in U/L) | 
| Dominant frequency of AF | Biological profil | LDH at 12 months (in U/L) | 
| Dominant frequency of AF | Biological profil | Creatinine level at pre-ablation (in µmol/L) | 
| Dominant frequency of AF | Biological profil | Creatinine level at 12 months (in µmol/L) | 
| Dominant frequency of AF | Biological profil | Clearance CKD-EPI at pre-ablation (ml/min/1.73m²) | 
| Dominant frequency of AF | Biological profil | Clearance CKD-EPI at 12 months (ml/min/1.73m²) | 
| Dominant frequency of AF | Biological profil | Urea at pre-ablation (mmol/L) | 
| Dominant frequency of AF | Biological profil | Urea at 12 months (mmol/L) | 
| Dominant frequency of AF | Biological profil | Protidemia at pre-ablation (g/L) | 
| Dominant frequency of AF | Biological profil | Protidemia at 12 months (g/L) | 
| Dominant frequency of AF | Biological profil | NTproBNP at pre-ablation (ng/L) | 
| Dominant frequency of AF | Biological profil | NTproBNP at 12 months (ng/L) | 
| Dominant frequency of AF | Biological profil | TSH at pre-ablation (mUI/L) | 
| Dominant frequency of AF | Biological profil | TSH at 12 months (mUI/L) | 
| Dominant frequency of AF | Biological profil | T3 at pre-ablation (pmol/L) | 
| Dominant frequency of AF | Biological profil | T3 at 12 months (pmol/L) | 
| Dominant frequency of AF | Biological profil | T4 at pre-ablation (pmol/L) | 
| Dominant frequency of AF | Biological profil | T4 at 12 months (pmol/L) | 
| Dominant frequency of AF | Biological profil | Galectin-3 at pre-ablation (in ng/mL) | 
| Dominant frequency of AF | Biological profil | Galectin-3 at 12 months (in ng/mL) | 
| Dominant frequency of AF | Biological profil | sST2 at pre-ablation (in ng/mL) | 
| Dominant frequency of AF | Biological profil | sST2 at 12 months (in ng/mL) | 
| Dominant frequency of AF | Biological profil | miRNAs at pre-ablation (fold change) | 
| Dominant frequency of AF | Biological profil | miRNAs at 12 months (fold change) | 
| Dominant frequency of AF | Diabete profil | Diabete at pre-ablation (yes, type I, type II or no) | 
| Dominant frequency of AF | Clinical exam | Body weight at pre-ablation (in kg) | 
| Dominant frequency of AF | Clinical exam | Body weight at 3 months (in kg) | 
| Dominant frequency of AF | Clinical exam | Body weight at 6 months (in kg) | 
| Dominant frequency of AF | Clinical exam | Body weight at 12 months (in kg) | 
| Dominant frequency of AF | Clinical exam | Body height at pre-ablation (in cm) | 
| Dominant frequency of AF | Clinical exam | Body height at 3 months (in cm) | 
| Dominant frequency of AF | Clinical exam | Body height at 6 months (in cm) | 
| Dominant frequency of AF | Clinical exam | Body height at 12 months (in cm) | 
| Dominant frequency of AF | Clinical exam | Systolic blood pressure at pre-ablation (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Systolic blood pressure at 3 months (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Systolic blood pressure at 6 months (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Systolic blood pressure at 12 months (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Diastolic blood pressure at pre-ablation (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Diastolic blood pressure at 3 months (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Diastolic blood pressure at 6 months (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Diastolic blood pressure at 12 months (in mmHg) | 
| Dominant frequency of AF | Clinical exam | Cardiac frequency pressure at pre-ablation (in bpm) | 
| Dominant frequency of AF | Clinical exam | Cardiac frequency pressure at 3 months (in bpm) | 
| Dominant frequency of AF | Clinical exam | Cardiac frequency pressure at 6 months (in bpm) | 
| Dominant frequency of AF | Clinical exam | Cardiac frequency pressure at 12 months (in bpm) | 
| Dominant frequency of AF | Clinical exam | NYHA score at pre-ablation (I, II, III or IV) | 
| Dominant frequency of AF | Clinical exam | NYHA score at 3 months (I, II, III or IV) | 
| Dominant frequency of AF | Clinical exam | NYHA score at 6 months (I, II, III or IV) | 
| Dominant frequency of AF | Clinical exam | NYHA score at 12 months (I, II, III or IV) | 
| Dominant frequency of AF | Clinical exam | Congestive signs at pre-ablation (yes, left, right, global; or not) | 
| Dominant frequency of AF | Clinical exam | Congestive signs at at 3 months (yes, left, right, global; or not) | 
| Dominant frequency of AF | Clinical exam | Congestive signs at 6 months (yes, left, right, global; or not) | 
| Dominant frequency of AF | Clinical exam | Congestive signs at 12 months (yes, left, right, global; or not) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation (AF), Myocardial fibrosis, AF ablation, AF recurrence, Biological collection, AF and myocardial fibrosis biological markers