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.
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 Type
OBSERVATIONAL
Enrollment
190
CHU clermont-ferrand
Clermont-Ferrand, France
RECRUITINGOccurrence of an atrial fibrillation recurrence
ECG 12 lead profile
Time frame: Any AF episode >30 seconds at pre-ablation (yes or no)
Occurrence of an atrial fibrillation recurrence
ECG 12 lead profile
Time frame: Any AF episode >30 seconds at 3 months (yes or no)
Occurrence of an atrial fibrillation recurrence
ECG 12 lead profile
Time frame: Any AF episode >30 seconds at 6 months (yes or no)
Occurrence of an atrial fibrillation recurrence
ECG 12 lead profile
Time frame: Any AF episode >30 seconds at 12 months (yes or no)
Occurrence of an atrial fibrillation recurrence
Holter ECG
Time frame: Any AF episode >30 seconds at pre-ablation (yes or no)
Occurrence of an atrial fibrillation recurrence
Holter ECG
Time frame: Any AF episode >30 seconds at 3 months (yes or no)
Occurrence of an atrial fibrillation recurrence
Holter ECG
Time frame: Any AF episode >30 seconds at 6 months (yes or no)
Occurrence of an atrial fibrillation recurrence
Holter ECG
Time frame: Any AF episode >30 seconds at 12 months (yes or no)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: PIIINP at pre-ablation (in ng/mL
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: PIIINP at 12 months (in ng/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: ICTP at pre-ablation (in ng/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: ICTP at 12 months (in ng/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: PICP at pre-ablation (in ng/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: PICP at 12 months (in ng/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: sRAGE at pre-ablation (in pg/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: sRAGE at 12 months (in pg/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: AGE at pre-ablation (in ng/mL)
Occurrence of an atrial fibrillation recurrence
Biological markers profil
Time frame: AGE at 12 months (in ng/mL)
Rate of fibrosis of the left atrium
IRM profile
Time frame: Degree of left atrial fibrosis on MRI at the inclusion (pre-ablation; in %)
Rate of fibrosis of the left atrium
Voltage mapping
Time frame: Endocardial left atria low voltage area (<0.5mV) in sinus rhythm (in %)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave frequency at the inclusion (pre-ablation; in ms)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave frequency at 3 months (in ms)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave frequency at 6 months (in ms)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave frequency at 12 months (in ms)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave amplitude at the inclusion (pre-ablation; in mv)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave amplitude at 3 months (in mv)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave amplitude at 6 months (in mv)
Dominant frequency of AF
ECG 12 lead profil
Time frame: F wave amplitude at 12 months (in mv)
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Dominant frequency of AF
ECG 12 lead profil
Time frame: AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent)
Dominant frequency of AF
ECG 12 lead profil
Time frame: AF characteristics at 3 months (paroxysmal, persistent)
Dominant frequency of AF
ECG 12 lead profil
Time frame: AF characteristics at 6 months (paroxysmal, persistent)
Dominant frequency of AF
ECG 12 lead profil
Time frame: AF characteristics at 12 months (paroxysmal, persistent)
Dominant frequency of AF
ECG 12 lead profil
Time frame: AF duration at the inclusion (pre-ablation, in ms)
Dominant frequency of AF
ECG 12 lead profil
Time frame: AF duration at 3 months (in ms)
Dominant frequency of AF
ECG 12 lead profil
Time frame: AF duration at 6 months (in ms)
Dominant frequency of AF
ECG 12 lead profil
Time frame: AF duration at 12 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave frequency at the inclusion (pre-ablation; in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave frequency at 3 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave frequency at 6 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave frequency at 9 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave frequency at 12 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave amplitude at the inclusion (pre-ablation; in mV)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave amplitude at 3 months (in mV)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave frequency at 6 months (in mV)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave amplitude at 9 months (in mV)
Dominant frequency of AF
Holter ECG profil
Time frame: F wave amplitude at 12 months (in mV)
Dominant frequency of AF
Holter ECG profil
Time frame: AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent)
Dominant frequency of AF
Holter ECG profil
Time frame: AF characteristics at 3 months (paroxysmal, persistent)
Dominant frequency of AF
Holter ECG profil
Time frame: AF characteristics at 6 months (paroxysmal, persistent)
Dominant frequency of AF
Holter ECG profil
Time frame: AF characteristics at 9 months (paroxysmal, persistent)
Dominant frequency of AF
Holter ECG profil
Time frame: AF characteristics at 12 months (paroxysmal, persistent)
Dominant frequency of AF
Holter ECG profil
Time frame: AF duration at the inclusion (pre-ablation; in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: AF duration at 3 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: AF duration at 6 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: AF duration at 9 months (in ms)
Dominant frequency of AF
Holter ECG profil
Time frame: AF duration at 12 months (in ms)
Dominant frequency of AF
Echocardiography
Time frame: Left atria volume at pre-ablation (mL)
Dominant frequency of AF
Echocardiography
Time frame: Left atria volume at 12 months (mL)
Dominant frequency of AF
Echocardiography
Time frame: Indexed left atria volume at pre-ablation (mL)
Dominant frequency of AF
Echocardiography
Time frame: Indexed left atria volume at 12 months (mL)
Dominant frequency of AF
Echocardiography
Time frame: LVEF at the inclusion (pre-ablation; %)
Dominant frequency of AF
Echocardiography
Time frame: LVEF at 12 months (%)
Dominant frequency of AF
Biological profil
Time frame: Hemoglobin at pre-ablation (in g/dL)
Dominant frequency of AF
Biological profil
Time frame: Hemoglobin at 12 months (in g/dL)
Dominant frequency of AF
Biological profil
Time frame: HbA1c at pre-ablation (in %)
Dominant frequency of AF
Biological profil
Time frame: HbA1c at 12 months (in %)
Dominant frequency of AF
Biological profil
Time frame: Kalemia at pre-ablation (in mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Kalemia at 12 months (in mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Natremia at pre-ablation (in mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Natremia at 12 months (in mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Glycemia at pre-ablation (in mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Glycemia at 12 months (in mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Total bilirubin at pre-ablation (in µmol/L)
Dominant frequency of AF
Biological profil
Time frame: Total bilirubin at 12 months (in µmol/L)
Dominant frequency of AF
Biological profil
Time frame: ASAT at pre-ablation (in U/L)
Dominant frequency of AF
Biological profil
Time frame: ASAT at 12 months (in U/L)
Dominant frequency of AF
Biological profil
Time frame: ALAT at pre-ablation (in U/L)
Dominant frequency of AF
Biological profil
Time frame: ALAT at 12 months (in U/L)
Dominant frequency of AF
Biological profil
Time frame: GGT at pre-ablation (in U/L)
Dominant frequency of AF
Biological profil
Time frame: GGT at 12 months (in U/L)
Dominant frequency of AF
Biological profil
Time frame: PAL at pre-ablation (in U/L)
Dominant frequency of AF
Biological profil
Time frame: PAL at 12 months (in U/L)
Dominant frequency of AF
Biological profil
Time frame: LDH at pre-ablation (in U/L)
Dominant frequency of AF
Biological profil
Time frame: LDH at 12 months (in U/L)
Dominant frequency of AF
Biological profil
Time frame: Creatinine level at pre-ablation (in µmol/L)
Dominant frequency of AF
Biological profil
Time frame: Creatinine level at 12 months (in µmol/L)
Dominant frequency of AF
Biological profil
Time frame: Clearance CKD-EPI at pre-ablation (ml/min/1.73m²)
Dominant frequency of AF
Biological profil
Time frame: Clearance CKD-EPI at 12 months (ml/min/1.73m²)
Dominant frequency of AF
Biological profil
Time frame: Urea at pre-ablation (mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Urea at 12 months (mmol/L)
Dominant frequency of AF
Biological profil
Time frame: Protidemia at pre-ablation (g/L)
Dominant frequency of AF
Biological profil
Time frame: Protidemia at 12 months (g/L)
Dominant frequency of AF
Biological profil
Time frame: NTproBNP at pre-ablation (ng/L)
Dominant frequency of AF
Biological profil
Time frame: NTproBNP at 12 months (ng/L)
Dominant frequency of AF
Biological profil
Time frame: TSH at pre-ablation (mUI/L)
Dominant frequency of AF
Biological profil
Time frame: TSH at 12 months (mUI/L)
Dominant frequency of AF
Biological profil
Time frame: T3 at pre-ablation (pmol/L)
Dominant frequency of AF
Biological profil
Time frame: T3 at 12 months (pmol/L)
Dominant frequency of AF
Biological profil
Time frame: T4 at pre-ablation (pmol/L)
Dominant frequency of AF
Biological profil
Time frame: T4 at 12 months (pmol/L)
Dominant frequency of AF
Biological profil
Time frame: Galectin-3 at pre-ablation (in ng/mL)
Dominant frequency of AF
Biological profil
Time frame: Galectin-3 at 12 months (in ng/mL)
Dominant frequency of AF
Biological profil
Time frame: sST2 at pre-ablation (in ng/mL)
Dominant frequency of AF
Biological profil
Time frame: sST2 at 12 months (in ng/mL)
Dominant frequency of AF
Biological profil
Time frame: miRNAs at pre-ablation (fold change)
Dominant frequency of AF
Biological profil
Time frame: miRNAs at 12 months (fold change)
Dominant frequency of AF
Diabete profil
Time frame: Diabete at pre-ablation (yes, type I, type II or no)
Dominant frequency of AF
Clinical exam
Time frame: Body weight at pre-ablation (in kg)
Dominant frequency of AF
Clinical exam
Time frame: Body weight at 3 months (in kg)
Dominant frequency of AF
Clinical exam
Time frame: Body weight at 6 months (in kg)
Dominant frequency of AF
Clinical exam
Time frame: Body weight at 12 months (in kg)
Dominant frequency of AF
Clinical exam
Time frame: Body height at pre-ablation (in cm)
Dominant frequency of AF
Clinical exam
Time frame: Body height at 3 months (in cm)
Dominant frequency of AF
Clinical exam
Time frame: Body height at 6 months (in cm)
Dominant frequency of AF
Clinical exam
Time frame: Body height at 12 months (in cm)
Dominant frequency of AF
Clinical exam
Time frame: Systolic blood pressure at pre-ablation (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Systolic blood pressure at 3 months (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Systolic blood pressure at 6 months (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Systolic blood pressure at 12 months (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Diastolic blood pressure at pre-ablation (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Diastolic blood pressure at 3 months (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Diastolic blood pressure at 6 months (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Diastolic blood pressure at 12 months (in mmHg)
Dominant frequency of AF
Clinical exam
Time frame: Cardiac frequency pressure at pre-ablation (in bpm)
Dominant frequency of AF
Clinical exam
Time frame: Cardiac frequency pressure at 3 months (in bpm)
Dominant frequency of AF
Clinical exam
Time frame: Cardiac frequency pressure at 6 months (in bpm)
Dominant frequency of AF
Clinical exam
Time frame: Cardiac frequency pressure at 12 months (in bpm)
Dominant frequency of AF
Clinical exam
Time frame: NYHA score at pre-ablation (I, II, III or IV)
Dominant frequency of AF
Clinical exam
Time frame: NYHA score at 3 months (I, II, III or IV)
Dominant frequency of AF
Clinical exam
Time frame: NYHA score at 6 months (I, II, III or IV)
Dominant frequency of AF
Clinical exam
Time frame: NYHA score at 12 months (I, II, III or IV)
Dominant frequency of AF
Clinical exam
Time frame: Congestive signs at pre-ablation (yes, left, right, global; or not)
Dominant frequency of AF
Clinical exam
Time frame: Congestive signs at at 3 months (yes, left, right, global; or not)
Dominant frequency of AF
Clinical exam
Time frame: Congestive signs at 6 months (yes, left, right, global; or not)
Dominant frequency of AF
Clinical exam
Time frame: Congestive signs at 12 months (yes, left, right, global; or not)