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Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment

Active, not recruiting
Conditions
Atrial Fibrillation
Interventions
Diagnostic Test: Proteomic analysis by antibody microarrays
Registration Number
NCT05170607
Lead Sponsor
National Medical Research Center for Therapy and Preventive Medicine
Brief Summary

The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to reveal the specific biomarkers by antibody microarrays.

Detailed Description

One hundred twenty patients with atrial fibrillation will participate in the study.

They will be divided into three groups.

1. Patients with AF recurrence after the first procedure but with isolated pulmonary veins at the beginning of the second AF ablation b)patients with AF recurrence after repeat PV ablation.

2. Patients with PV-associated atrial fibrillation. The group will be included patients with freedom of atrial fibrillation after PV isolation (first or repeat procedure).

3. Healthy volunteers

Groups would be formed from patients who previously underwent atrial fibrillation ablations and whose blood samples have been taken and placed in a biobank before interventional treatment. The first step will include proteomic serum profiling using antibody microarrays in ten subjects will be split into 3 groups. The second step will include validation of selected protein biomarkers, in the total cohort (N=120).

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
120
Inclusion Criteria

• Patient with paroxysmal/persistent atrial fibrillation who underwent interventional treatment

Exclusion Criteria
  • permanent AF
  • contraindications to oral anticoagulation or heparin
  • chronic kidney disease requiring dialysis
  • untreated hypo- or hyperthyroidism
  • breast feeding
  • pregnancy
  • chronic kidney disease requiring dialysis
  • decompensated heart failure
  • stroke within the last 3 months
  • myocardial infarction within the last 3 months
  • Percutaneous coronary intervention or Coronary Artery Bypass Grafting within the last 3 months
  • active myocarditis
  • artificial valve replacement surgery
  • severe mitral or aortic stenosis
  • coronary artery disease requiring revascularization
  • heart transplant

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Healthy volunteersProteomic analysis by antibody microarrays-
PV associated atrial fibrillationProteomic analysis by antibody microarrays-
non-PV associated arrhythmic focusesProteomic analysis by antibody microarrays-
Primary Outcome Measures
NameTimeMethod
proteins after validation1 year

number of protein which will be specific for non-PV associated arrhythmic focuses group after validation

Secondary Outcome Measures
NameTimeMethod
proteins after screening1 year

number of protein which will be specific for non-PV associated arrhythmic focuses group after screening

Trial Locations

Locations (1)

National Research Center for Preventive Medicine

🇷🇺

Moscow, Russian Federation

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