Able to Give His Non Opposition to Participate to the Study, 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
Conditions
Keywords
Atrial fibrillation (AF), Myocardial fibrosis, AF ablation, AF recurrence, Biological collection, AF and myocardial fibrosis biological markers
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.
Interventions
None listed
Sponsors
Groupama foundation
Biochemistry Lab University Hospital Clermont-Ferrand
University Hospital, Clermont-Ferrand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of an atrial fibrillation recurrence | Any AF episode >30 seconds at pre-ablation (yes or no) | ECG 12 lead profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of fibrosis of the left atrium | Degree of left atrial fibrosis on MRI at the inclusion (pre-ablation; in %) | IRM profile |
| Dominant frequency of AF | F wave frequency at the inclusion (pre-ablation; in ms) | ECG 12 lead profil |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed