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AzTrials

Women and Men Over 18 Years OldPROFIB-AFNCT05179902

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

An observational study of Women and Men Over 18 Years Old and AF Ablation (ECS recommendation2020&ACS2014) Either for Paroxysmal AF Unresponsive to Anti-arrhythmic Treatment Either for Persisting Symptomatic AF, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
190 participants
Where
1 siteFrance
Study dates
20 Jan 2022to Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Lise Laclautre contact

334.73.754.963

promo_interne_drci@chu-clermontferrand.fr

France1 site, 1 recruiting

  • CHU clermont-ferrand

    Clermont-Ferrand

    Lise Laclautre

    Grégoire Massoulié

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Read the 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.

Keywords
Atrial fibrillation (AF), Myocardial fibrosis, AF ablation, AF recurrence, Biological collection, AF and myocardial fibrosis biological markers
Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of an atrial fibrillation recurrence

    ECG 12 lead profile

    Measured: Any AF episode >30 seconds at pre-ablation (yes or no)

  2. Occurrence of an atrial fibrillation recurrence

    ECG 12 lead profile

    Measured: Any AF episode >30 seconds at 3 months (yes or no)

  3. Occurrence of an atrial fibrillation recurrence

    ECG 12 lead profile

    Measured: Any AF episode >30 seconds at 6 months (yes or no)

  4. Occurrence of an atrial fibrillation recurrence

    ECG 12 lead profile

    Measured: Any AF episode >30 seconds at 12 months (yes or no)

  5. Occurrence of an atrial fibrillation recurrence

    Holter ECG

    Measured: Any AF episode >30 seconds at pre-ablation (yes or no)

  6. Occurrence of an atrial fibrillation recurrence

    Holter ECG

    Measured: Any AF episode >30 seconds at 3 months (yes or no)

  7. Occurrence of an atrial fibrillation recurrence

    Holter ECG

    Measured: Any AF episode >30 seconds at 6 months (yes or no)

  8. Occurrence of an atrial fibrillation recurrence

    Holter ECG

    Measured: Any AF episode >30 seconds at 12 months (yes or no)

  9. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: PIIINP at pre-ablation (in ng/mL

  10. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: PIIINP at 12 months (in ng/mL)

  11. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: ICTP at pre-ablation (in ng/mL)

  12. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: ICTP at 12 months (in ng/mL)

  13. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: PICP at pre-ablation (in ng/mL)

  14. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: PICP at 12 months (in ng/mL)

  15. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: sRAGE at pre-ablation (in pg/mL)

  16. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: sRAGE at 12 months (in pg/mL)

  17. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: AGE at pre-ablation (in ng/mL)

  18. Occurrence of an atrial fibrillation recurrence

    Biological markers profil

    Measured: AGE at 12 months (in ng/mL)

Secondary outcomes (117)

  1. Rate of fibrosis of the left atrium

    IRM profile

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

  2. Rate of fibrosis of the left atrium

    Voltage mapping

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

  3. Dominant frequency of AF

    ECG 12 lead profil

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

  4. Dominant frequency of AF

    ECG 12 lead profil

    Measured: F wave frequency at 3 months (in ms)

  5. Dominant frequency of AF

    ECG 12 lead profil

    Measured: F wave frequency at 6 months (in ms)

  6. Dominant frequency of AF

    ECG 12 lead profil

    Measured: F wave frequency at 12 months (in ms)

  7. Dominant frequency of AF

    ECG 12 lead profil

    Measured: F wave amplitude at the inclusion (pre-ablation; in mv)

  8. Dominant frequency of AF

    ECG 12 lead profil

    Measured: F wave amplitude at 3 months (in mv)

  9. Dominant frequency of AF

    ECG 12 lead profil

    Measured: F wave amplitude at 6 months (in mv)

  10. Dominant frequency of AF

    ECG 12 lead profil

    Measured: F wave amplitude at 12 months (in mv)

  11. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent)

  12. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF characteristics at 3 months (paroxysmal, persistent)

  13. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF characteristics at 6 months (paroxysmal, persistent)

  14. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF characteristics at 12 months (paroxysmal, persistent)

  15. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF duration at the inclusion (pre-ablation, in ms)

  16. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF duration at 3 months (in ms)

  17. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF duration at 6 months (in ms)

  18. Dominant frequency of AF

    ECG 12 lead profil

    Measured: AF duration at 12 months (in ms)

  19. Dominant frequency of AF

    Holter ECG profil

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

  20. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave frequency at 3 months (in ms)

  21. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave frequency at 6 months (in ms)

  22. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave frequency at 9 months (in ms)

  23. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave frequency at 12 months (in ms)

  24. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave amplitude at the inclusion (pre-ablation; in mV)

  25. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave amplitude at 3 months (in mV)

  26. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave frequency at 6 months (in mV)

  27. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave amplitude at 9 months (in mV)

  28. Dominant frequency of AF

    Holter ECG profil

    Measured: F wave amplitude at 12 months (in mV)

  29. Dominant frequency of AF

    Holter ECG profil

    Measured: AF characteristics at the inclusion (pre-ablation; paroxysmal, persistent)

  30. Dominant frequency of AF

    Holter ECG profil

    Measured: AF characteristics at 3 months (paroxysmal, persistent)

  31. Dominant frequency of AF

    Holter ECG profil

    Measured: AF characteristics at 6 months (paroxysmal, persistent)

  32. Dominant frequency of AF

    Holter ECG profil

    Measured: AF characteristics at 9 months (paroxysmal, persistent)

  33. Dominant frequency of AF

    Holter ECG profil

    Measured: AF characteristics at 12 months (paroxysmal, persistent)

  34. Dominant frequency of AF

    Holter ECG profil

    Measured: AF duration at the inclusion (pre-ablation; in ms)

  35. Dominant frequency of AF

    Holter ECG profil

    Measured: AF duration at 3 months (in ms)

  36. Dominant frequency of AF

    Holter ECG profil

    Measured: AF duration at 6 months (in ms)

  37. Dominant frequency of AF

    Holter ECG profil

    Measured: AF duration at 9 months (in ms)

  38. Dominant frequency of AF

    Holter ECG profil

    Measured: AF duration at 12 months (in ms)

  39. Dominant frequency of AF

    Echocardiography

    Measured: Left atria volume at pre-ablation (mL)

  40. Dominant frequency of AF

    Echocardiography

    Measured: Left atria volume at 12 months (mL)

  41. Dominant frequency of AF

    Echocardiography

    Measured: Indexed left atria volume at pre-ablation (mL)

  42. Dominant frequency of AF

    Echocardiography

    Measured: Indexed left atria volume at 12 months (mL)

  43. Dominant frequency of AF

    Echocardiography

    Measured: LVEF at the inclusion (pre-ablation; %)

  44. Dominant frequency of AF

    Echocardiography

    Measured: LVEF at 12 months (%)

  45. Dominant frequency of AF

    Biological profil

    Measured: Hemoglobin at pre-ablation (in g/dL)

  46. Dominant frequency of AF

    Biological profil

    Measured: Hemoglobin at 12 months (in g/dL)

  47. Dominant frequency of AF

    Biological profil

    Measured: HbA1c at pre-ablation (in %)

  48. Dominant frequency of AF

    Biological profil

    Measured: HbA1c at 12 months (in %)

  49. Dominant frequency of AF

    Biological profil

    Measured: Kalemia at pre-ablation (in mmol/L)

  50. Dominant frequency of AF

    Biological profil

    Measured: Kalemia at 12 months (in mmol/L)

  51. Dominant frequency of AF

    Biological profil

    Measured: Natremia at pre-ablation (in mmol/L)

  52. Dominant frequency of AF

    Biological profil

    Measured: Natremia at 12 months (in mmol/L)

  53. Dominant frequency of AF

    Biological profil

    Measured: Glycemia at pre-ablation (in mmol/L)

  54. Dominant frequency of AF

    Biological profil

    Measured: Glycemia at 12 months (in mmol/L)

  55. Dominant frequency of AF

    Biological profil

    Measured: Total bilirubin at pre-ablation (in µmol/L)

  56. Dominant frequency of AF

    Biological profil

    Measured: Total bilirubin at 12 months (in µmol/L)

  57. Dominant frequency of AF

    Biological profil

    Measured: ASAT at pre-ablation (in U/L)

  58. Dominant frequency of AF

    Biological profil

    Measured: ASAT at 12 months (in U/L)

  59. Dominant frequency of AF

    Biological profil

    Measured: ALAT at pre-ablation (in U/L)

  60. Dominant frequency of AF

    Biological profil

    Measured: ALAT at 12 months (in U/L)

  61. Dominant frequency of AF

    Biological profil

    Measured: GGT at pre-ablation (in U/L)

  62. Dominant frequency of AF

    Biological profil

    Measured: GGT at 12 months (in U/L)

  63. Dominant frequency of AF

    Biological profil

    Measured: PAL at pre-ablation (in U/L)

  64. Dominant frequency of AF

    Biological profil

    Measured: PAL at 12 months (in U/L)

  65. Dominant frequency of AF

    Biological profil

    Measured: LDH at pre-ablation (in U/L)

  66. Dominant frequency of AF

    Biological profil

    Measured: LDH at 12 months (in U/L)

  67. Dominant frequency of AF

    Biological profil

    Measured: Creatinine level at pre-ablation (in µmol/L)

  68. Dominant frequency of AF

    Biological profil

    Measured: Creatinine level at 12 months (in µmol/L)

  69. Dominant frequency of AF

    Biological profil

    Measured: Clearance CKD-EPI at pre-ablation (ml/min/1.73m²)

  70. Dominant frequency of AF

    Biological profil

    Measured: Clearance CKD-EPI at 12 months (ml/min/1.73m²)

  71. Dominant frequency of AF

    Biological profil

    Measured: Urea at pre-ablation (mmol/L)

  72. Dominant frequency of AF

    Biological profil

    Measured: Urea at 12 months (mmol/L)

  73. Dominant frequency of AF

    Biological profil

    Measured: Protidemia at pre-ablation (g/L)

  74. Dominant frequency of AF

    Biological profil

    Measured: Protidemia at 12 months (g/L)

  75. Dominant frequency of AF

    Biological profil

    Measured: NTproBNP at pre-ablation (ng/L)

  76. Dominant frequency of AF

    Biological profil

    Measured: NTproBNP at 12 months (ng/L)

  77. Dominant frequency of AF

    Biological profil

    Measured: TSH at pre-ablation (mUI/L)

  78. Dominant frequency of AF

    Biological profil

    Measured: TSH at 12 months (mUI/L)

  79. Dominant frequency of AF

    Biological profil

    Measured: T3 at pre-ablation (pmol/L)

  80. Dominant frequency of AF

    Biological profil

    Measured: T3 at 12 months (pmol/L)

  81. Dominant frequency of AF

    Biological profil

    Measured: T4 at pre-ablation (pmol/L)

  82. Dominant frequency of AF

    Biological profil

    Measured: T4 at 12 months (pmol/L)

  83. Dominant frequency of AF

    Biological profil

    Measured: Galectin-3 at pre-ablation (in ng/mL)

  84. Dominant frequency of AF

    Biological profil

    Measured: Galectin-3 at 12 months (in ng/mL)

  85. Dominant frequency of AF

    Biological profil

    Measured: sST2 at pre-ablation (in ng/mL)

  86. Dominant frequency of AF

    Biological profil

    Measured: sST2 at 12 months (in ng/mL)

  87. Dominant frequency of AF

    Biological profil

    Measured: miRNAs at pre-ablation (fold change)

  88. Dominant frequency of AF

    Biological profil

    Measured: miRNAs at 12 months (fold change)

  89. Dominant frequency of AF

    Diabete profil

    Measured: Diabete at pre-ablation (yes, type I, type II or no)

  90. Dominant frequency of AF

    Clinical exam

    Measured: Body weight at pre-ablation (in kg)

  91. Dominant frequency of AF

    Clinical exam

    Measured: Body weight at 3 months (in kg)

  92. Dominant frequency of AF

    Clinical exam

    Measured: Body weight at 6 months (in kg)

  93. Dominant frequency of AF

    Clinical exam

    Measured: Body weight at 12 months (in kg)

  94. Dominant frequency of AF

    Clinical exam

    Measured: Body height at pre-ablation (in cm)

  95. Dominant frequency of AF

    Clinical exam

    Measured: Body height at 3 months (in cm)

  96. Dominant frequency of AF

    Clinical exam

    Measured: Body height at 6 months (in cm)

  97. Dominant frequency of AF

    Clinical exam

    Measured: Body height at 12 months (in cm)

  98. Dominant frequency of AF

    Clinical exam

    Measured: Systolic blood pressure at pre-ablation (in mmHg)

  99. Dominant frequency of AF

    Clinical exam

    Measured: Systolic blood pressure at 3 months (in mmHg)

  100. Dominant frequency of AF

    Clinical exam

    Measured: Systolic blood pressure at 6 months (in mmHg)

  101. Dominant frequency of AF

    Clinical exam

    Measured: Systolic blood pressure at 12 months (in mmHg)

  102. Dominant frequency of AF

    Clinical exam

    Measured: Diastolic blood pressure at pre-ablation (in mmHg)

  103. Dominant frequency of AF

    Clinical exam

    Measured: Diastolic blood pressure at 3 months (in mmHg)

  104. Dominant frequency of AF

    Clinical exam

    Measured: Diastolic blood pressure at 6 months (in mmHg)

  105. Dominant frequency of AF

    Clinical exam

    Measured: Diastolic blood pressure at 12 months (in mmHg)

  106. Dominant frequency of AF

    Clinical exam

    Measured: Cardiac frequency pressure at pre-ablation (in bpm)

  107. Dominant frequency of AF

    Clinical exam

    Measured: Cardiac frequency pressure at 3 months (in bpm)

  108. Dominant frequency of AF

    Clinical exam

    Measured: Cardiac frequency pressure at 6 months (in bpm)

  109. Dominant frequency of AF

    Clinical exam

    Measured: Cardiac frequency pressure at 12 months (in bpm)

  110. Dominant frequency of AF

    Clinical exam

    Measured: NYHA score at pre-ablation (I, II, III or IV)

  111. Dominant frequency of AF

    Clinical exam

    Measured: NYHA score at 3 months (I, II, III or IV)

  112. Dominant frequency of AF

    Clinical exam

    Measured: NYHA score at 6 months (I, II, III or IV)

  113. Dominant frequency of AF

    Clinical exam

    Measured: NYHA score at 12 months (I, II, III or IV)

  114. Dominant frequency of AF

    Clinical exam

    Measured: Congestive signs at pre-ablation (yes, left, right, global; or not)

  115. Dominant frequency of AF

    Clinical exam

    Measured: Congestive signs at at 3 months (yes, left, right, global; or not)

  116. Dominant frequency of AF

    Clinical exam

    Measured: Congestive signs at 6 months (yes, left, right, global; or not)

  117. Dominant frequency of AF

    Clinical exam

    Measured: Congestive signs at 12 months (yes, left, right, global; or not)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start20 Jan 2022
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179902
Sponsor's protocol ID
RNI 2021 MASSOULIE
Other IDs
2021-A02091-40
Acronym
PROFIB-AF
Status last verified
Feb 2022
First submitted
17 Dec 2021
Last updated
2 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Women and Men Over 18 Years Old and AF Ablation (ECS recommendation2020&ACS2014) Either for Paroxysmal AF Unresponsive to Anti-arrhythmic Treatment Either for Persisting Symptomatic AF, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of an atrial fibrillation recurrence (time frame: Any AF episode >30 seconds at pre-ablation (yes or no)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05179902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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