NCT05170607

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2021Jan 2028

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

7.1 years

First QC Date

December 24, 2021

Last Update Submit

August 24, 2026

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationprotein microarrayproteomic biomarkersPV dependent atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • proteins after validation

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

    1 year

Secondary Outcomes (1)

  • proteins after screening

    1 year

Study Arms (3)

PV associated atrial fibrillation

Diagnostic Test: Proteomic analysis by antibody microarrays

non-PV associated arrhythmic focuses

Diagnostic Test: Proteomic analysis by antibody microarrays

Healthy volunteers

Diagnostic Test: Proteomic analysis by antibody microarrays

Interventions

Proteomic analysis by antibody microarraysDIAGNOSTIC_TEST

Proteomic analysis by antibody microarrays can be used to identify novel biomarkers and to investigate various signaling pathways including protein phosphorylation and protein-protein interactions. Microchips are manufactured as a matrix of a number of immobilized antibodies covalently bound to the glass, membrane, or gel surfaces. Microchips are used for serum proteomic studies in patients with cardiovascular diseases and cancer

Healthy volunteersPV associated atrial fibrillationnon-PV associated arrhythmic focuses

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18-85 years old with s paroxismal or persistant atrial fibrillation and prior interventional treatment

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Center for Preventive Medicine

Moscow, 101990, Russia

Location

Related Publications (2)

  • Gumanova NG, Zlobina PD, Bogdanova NL, Brutyan HA, Kalemberg EN, Havrichenko YI, Davtyan KV, Drapkina OM. Atrial fibrillation recurrence after catheter ablation is associated with RAD51 and p63 proteins. Heliyon. 2024 Jun 13;10(12):e32874. doi: 10.1016/j.heliyon.2024.e32874. eCollection 2024 Jun 30.

    PMID: 38988509BACKGROUND

  • Davtyan KV, Abdullaeva AA, Gumanova NG, Bogdanova NL, Brutyan HA, Kalemberg EN, Bazaeva EV, Kharlap MS, Serdyuk SE, Drapkina OM. Atrial Fibrillation Recurrence After Catheter Ablation Is Associated with TAG72 Protein. J Cardiovasc Dev Dis. 2026 Jan 9;13(1):39. doi: 10.3390/jcdd13010039.

    PMID: 41590866RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

December 24, 2021

First Posted

December 28, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations

RU(1)