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

NCT05179902 | Unknown

• 2 other identifiers: RNI 2021 MASSOULIE2021-A02091-40
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Atrial fibrillation (AF); Myocardial fibrosis; AF ablation; AF recurrence; Biological collection; AF and myocardial fibrosis biological markers

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (117)

• Rate of fibrosis of the left atrium

  Degree of left atrial fibrosis on MRI at the inclusion (pre-ablation; in %)

• Rate of fibrosis of the left atrium

  Endocardial left atria low voltage area (<0.5mV) in sinus rhythm (in %)

• Dominant frequency of AF

  F wave frequency at the inclusion (pre-ablation; in ms)

• Dominant frequency of AF

  F wave frequency at 3 months (in ms)

• Dominant frequency of AF

  F wave frequency at 6 months (in ms)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Major patient 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Groupama foundation: collaborator
• Biochemistry Lab University Hospital Clermont-Ferrand: collaborator

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grégoire Massoulié

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: January 20, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 2, 2022

Record last verified: 2022-02

Locations

FR (1)