NCT06735001

Brief Summary

Atrial fibrillation (AF) is a major public health problem. The efficacy of the existing techniques is limited in the more aggressive forms. It is therefore necessary to develop approaches, in particular the identification of relevant biomarkers, to prevent the onset, recurrence or progression of AF in at-risk patients. The objective of this study is to describe the longitudinal metabolic and biomolecular signature of AF in patients eligible for cardiac ablation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Mar 2025Apr 2027

First Submitted

Initial submission to the registry

November 21, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

November 21, 2024

Last Update Submit

March 28, 2025

Conditions

Keywords

atrial fibrillationpreventionbiomarkerscardiac metabolism

Outcome Measures

Primary Outcomes (3)

  • Biomarkers T1

    The individuation of biomarkers uniquely present in AF patients - compared to control groups.

    Day 0

  • Biomarkers T2

    The individuation of biomarkers uniquely present in AF patients - compared to control groups.

    Day 1

  • Biomarkers 2

    The identification of biomarkers predictive of the risk of AF recurrence

    12 months

Secondary Outcomes (1)

  • Algorithm

    Month 12

Study Arms (2)

Patients with FA

OTHER

Patient with a documented Fibrillation Atrial within the last 18 months

Procedure: FA ablationBiological: Lab test

Patients without FA

OTHER

Patient without Fibrillation Atrial

Biological: Lab test

Interventions

FA ablationPROCEDURE

Ablation of the FA

Patients with FA
Lab testBIOLOGICAL

Blood collection

Patients with FAPatients without FA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years, all genders, and ethnic origins
  • Free, informed, and written consent signed
  • Person affiliated to or benefiting from a social security scheme

You may not qualify if:

  • Age \< 18 years
  • Lack of informed consent
  • Gestating women (pregnancy test carried out as part of care for FA patients, contraception, or menopause for women in control groups)
  • Persons under administrative or judicial protection
  • Endocarditis or pericarditis in progress or within the 3 last months
  • Active tumor pathology (benign or malignant)
  • Chronic inflammation or autoimmune disease
  • Chronic liver disease
  • Myocardial infarction within the last 8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Bordeaux

Pessac, 33604, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas DERVAL

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: prospective multicentric study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2024

First Posted

December 16, 2024

Study Start

March 10, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations