Atrial FibrillationNCT05170607
Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment
An observational study of Atrial Fibrillation, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Proteomic analysis by antibody microarrays
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2021to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients 18-85 years old with s paroxismal or persistant atrial fibrillation and prior interventional treatment
Who may be able to join
- Patient with paroxysmal/persistent atrial fibrillation who underwent interventional treatment
Who cannot join
- permanent AF
- contraindications to oral anticoagulation or heparin
- chronic kidney disease requiring dialysis
- untreated hypo- or hyperthyroidism
- breast feeding
- pregnancy
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
One hundred twenty patients with atrial fibrillation will participate in the study.
They will be divided into three groups.
- 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.
- Patients with PV-associated atrial fibrillation. The group will be included patients with freedom of atrial fibrillation after PV isolation (first or repeat procedure).
- 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Proteomic analysis by antibody microarrays
- Keywords
- atrial fibrillation, protein microarray, proteomic biomarkers, PV dependent atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| PV associated atrial fibrillation | Not described Receives: Diagnostic Test: Proteomic analysis by antibody microarrays | |
| non-PV associated arrhythmic focuses | Not described Receives: Diagnostic Test: Proteomic analysis by antibody microarrays | |
| Healthy volunteers | Not described Receives: Diagnostic Test: Proteomic analysis by antibody microarrays |
What is being measured
The primary outcome is the main question the study is designed to answer.
proteins after validation
number of protein which will be specific for non-PV associated arrhythmic focuses group after validation
Measured: 1 year
Secondary outcomes (1)
proteins after screening
number of protein which will be specific for non-PV associated arrhythmic focuses group after screening
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jan 2021
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170607
- Sponsor's protocol ID
- 121122200154-7
- Status last verified
- Aug 2026
- First submitted
- 24 Dec 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38988509Davtyan 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.
PubMed 41590866
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment
- ClinicalTrials.gov ID
- NCT05170607
- Acronym / sponsor ID
- 121122200154-7
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, protein microarray, proteomic biomarkers, PV dependent atrial fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Patients with PV-associated atrial fibrillation. The group will be included patients with freedom of atrial fibrillation after PV isolation (first or repeat procedure).
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients 18-85 years old with s paroxismal or persistant atrial fibrillation and prior interventional treatment
Key inclusion criteria (1 listed)
- Patient with paroxysmal/persistent atrial fibrillation who underwent interventional treatment
Key exclusion criteria (16 listed)
- permanent AF
- contraindications to oral anticoagulation or heparin
- chronic kidney disease requiring dialysis
- untreated hypo- or hyperthyroidism
- breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteomic analysis by antibody microarraysProteomic 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 | Diagnostic test | Healthy volunteers, PV associated atrial fibrillation, non-PV associated arrhythmic focuses |
Primary outcome
proteins after validation
Time frame: 1 year
number of protein which will be specific for non-PV associated arrhythmic focuses group after validation
1 secondary outcome
proteins after screening
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 38988509Gumanova 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.
- Results publication: PubMed 41590866Davtyan 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
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 1 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proteins after validation (time frame: 1 year). 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 NCT05170607, which also lists 2 linked publications.
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 26 Aug 2026.