Atrial FibrillationNCT07348991
Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG
An observational study of Atrial Fibrillation and Atrioventricular Block, Second and Third Degree, run by I.M. Sechenov First Moscow State Medical University.
Trial summary
During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices. This ECG is analyzed for time, amplitude, and frequency parameters-more than 200 parameters per cardiac cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrioventricular Block, Second and Third Degree, Sinus Node Dysfunction
- What is being tested?
- digital single-channel ECG recording
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 30 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will analyze patients undergoing elective high-risk cardiac surgeries, including cardiac surgery, aortic surgery, esophageal and gastric cardia surgery, and thoracic surgery. Patients undergoing large-scale oncological surgeries will also be included.
Who may be able to join
- Patients over 18 years of age;
- Scheduled surgery with high cardiac risk
- Informed consent was given to participate in the study
Who cannot join
- Cancellation of the surgery for any reason;
- The patient's unwillingness to continue participating in the study;
- Poor quality of the ECG recording on a single-channel ECG monitor.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predicting Atrial Fibrillation and Life-threatening Cardiac Arrhythmias and Conduction Disorders in the Perioperative Period in High Cardiac Risk Surgery Using Artificial Intelligence Elements
During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices. This ECG is analyzed for time, amplitude, and frequency parameters-more than 200 parameters per cardiac cycle. Additionally, the available parameters of a standard 12-lead ECG recording are determined. All parameters of both single-lead and 12-lead ECGs will be included in a multivariate regression analysis to determine the optimal method for predicting atrial fibrillation, life-threatening cardiac arrhythmias, and conduction abnormalities in the perioperative period after high-risk cardiac procedures.
The study will include patients undergoing high-risk cardiac surgeries, such as those on the heart, aorta, esophagus, pancreas, liver, and lungs, as well as high-risk oncological surgeries. A partial analysis will also be performed depending on the type of intervention. Rhythm and conduction disturbances will be recorded during surgery, as well as in the postoperative period, using ECG monitors, 24-hour ECG monitoring, and repeated recordings of a standard ECG when complaints or signs of unstable hemodynamics arise
Read the detailed description
In study, the investigators plan to identify single-channel and 12-lead ECG parameters that correlate significantly with the occurrence of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disturbances in the perioperative period after high-risk cardiac interventions.
A prospective, non-randomized, observational, controlled, single-center study consisting of two consecutive stages is being conducted.
The first stage involves identifying single-channel and 12-lead ECG parameters that correlate significantly with the onset of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk. Participants who meet the inclusion criteria will undergo the following during preoperative preparation: recording of a digital single-channel ECG using the CardioQVARK software and hardware complex (CardioQVARK medical device (Electrocardiograph) issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare) P3H 2024/22855, issued on June 5, 2024); a digital 12-lead ECG; an extended echocardiographic examination; and 24-hour Holter ECG monitoring.
The single-channel ECG will be recorded for 3 minutes at rest in a sitting position. The participants leans back against the back of the chair, legs uncrossed, arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex.
Next, the parameters of single-channel and 12-channel ECG are identified that have a reliable correlation with the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk, followed by the creation of a machine learning model and/or or neural network analysis with deep learning support for predicting the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders.
The second stage will involve testing using a test sample of the algorithm, taking into account the ECG parameters which, according to the statistical analysis performed in the first stage, had the highest sensitivity and specificity in predicting the onset of atrial fibrillation and life-threatening cardiac arrhythmias and conductions disorders.
- Conditions
- Atrial Fibrillation, Atrioventricular Block, Second and Third Degree, Sinus Node Dysfunction, Ventricular Tachycardia (VT), Ventricular Fibrillation
- Being tested
- digital single-channel ECG recording
- Keywords
- Electrocardiogram, Artificial intelligence, Cardiac arrhythmias, Atrioventricular block, Perioperative, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Atrioventricular Block, Neoplasm Metastasis, Sick Sinus Syndrome, Tachycardia, Ventricular, Ventricular Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital single-channel ECG recordingDiagnostic test
A single-channel ECG will be recorded for 3 minutes while the patient is sitting at rest. The patient leans back against the chair, legs uncrossed, and arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex (CardioQVARK medical device (Electrocardiograph) issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare) P3H 2024/22855, issued on June 5, 2024).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | patients meeting the inclusion criteria who are hospitalised for surgery with a high cardiovascular risk Receives: Diagnostic Test: digital single-channel ECG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy
statistical parameter of diagnostic and prognostic accuracy of the method under study
Measured: 30 days after sugery starts
specificity, sensitivity, prognostic significance of a positive and negative result, prognostic significance of a positive and positive result, diagnostic accuracy
statistical parameter of diagnostic and prognostic accuracy of the method under study
Measured: perioperative period - from the surgery starts till 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start31 Dec 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 May 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348991
- Sponsor's protocol ID
- ChPSH1
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Paroxysms of atrial fibrillation during planned cardiac surgery under artificial circulation / E. P. Gulyaeva-Seltsovskaya, I. Dkhif, A. A. Mols [et al.] // Bulletin of the Smolensk State Medical Academy. - 2023. - Vol. 22, No. 4. - P. 100-106. - DOI 10.37903/vsgma.2023.4.14. - EDN MIIWSU
Chomakhidze P.Sh., Kurbanalieva N.K., Nebezhev A.A., Sedov V.P., Syrkin A.L. Modern aspects of preoperative examination in planned extracardiac interventions. Consilium Medicum. 2025;27(1): DOI: 10.26442/20751753.2025.1.203060 © CONSILIUM MEDICUM LLC, 2025
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Atrial Fibrillation and Life-threatening Cardiac Arrhythmias and Conduction Disorders in the Perioperative Period in High Cardiac Risk Surgery Using Artificial Intelligence Elements
- ClinicalTrials.gov ID
- NCT07348991
- Acronym / sponsor ID
- ChPSH1
- Conditions
- Atrial Fibrillation, Atrioventricular Block, Second and Third Degree, Sinus Node Dysfunction, Ventricular Tachycardia (VT), Ventricular Fibrillation
- Keywords
- Electrocardiogram, Artificial intelligence, Cardiac arrhythmias, Atrioventricular block, Perioperative, Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 16 Jan 2026 (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.
During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices. This ECG is analyzed for time, amplitude, and frequency parameters-more than 200 parameters per cardiac cycle. Additionally, the available parameters of a standard 12-lead ECG recording are determined. All parameters of both single-lead and 12-lead ECGs will be included in a multivariate regression analysis to determine the optimal method for predicting atrial fibrillation, life-threatening cardiac arrhythmias, and conduction abnormalities in the perioperative period after high-risk cardiac procedures.
The study will include patients undergoing high-risk cardiac surgeries, such as those on the heart, aorta, esophagus, pancreas, liver, and lungs, as well as high-risk oncological surgeries. A partial analysis will also be performed depending on the type of intervention. Rhythm and conduction disturbances will be recorded during surgery, as well as in the postoperative period, using ECG monitors, 24-hour ECG monitoring, and repeated recordings of a standard ECG when complaints or signs of unstable hemodynamics arise
Detailed description
In study, the investigators plan to identify single-channel and 12-lead ECG parameters that correlate significantly with the occurrence of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disturbances in the perioperative period after high-risk cardiac interventions.
A prospective, non-randomized, observational, controlled, single-center study consisting of two consecutive stages is being conducted.
The first stage involves identifying single-channel and 12-lead ECG parameters that correlate significantly with the onset of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk. Participants who meet the inclusion criteria will undergo the following during preoperative preparation: recording of a digital single-channel ECG using the CardioQVARK software and hardware complex (CardioQVARK medical device (Electrocardiograph) issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare) P3H 2024/22855, issued on June 5, 2024); a digital 12-lead ECG; an extended echocardiographic examination; and 24-hour Holter ECG monitoring.
The single-channel ECG will be recorded for 3 minutes at rest in a sitting position. The participants leans back against the back of the chair, legs uncrossed, arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex.
Next, the parameters of single-channel and 12-channel ECG are identified that have a reliable correlation with the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk, followed by the creation of a machine learning model and/or or neural network analysis with deep learning support for predicting the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders.
The second stage will involve testing using a test sample of the algorithm, taking into account the ECG parameters which, according to the statistical analysis performed in the first stage, had the highest sensitivity and specificity in predicting the onset of atrial fibrillation and life-threatening cardiac arrhythmias and conductions disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Diagnostic Test: digital single-channel ECG recordingpatients meeting the inclusion criteria who are hospitalised for surgery with a high cardiovascular risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will analyze patients undergoing elective high-risk cardiac surgeries, including cardiac surgery, aortic surgery, esophageal and gastric cardia surgery, and thoracic surgery. Patients undergoing large-scale oncological surgeries will also be included.
Key inclusion criteria (3 listed)
- Patients over 18 years of age;
- Scheduled surgery with high cardiac risk
- Informed consent was given to participate in the study
Key exclusion criteria (3 listed)
- Cancellation of the surgery for any reason;
- The patient's unwillingness to continue participating in the study;
- Poor quality of the ECG recording on a single-channel ECG monitor.
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 |
|---|---|---|
| digital single-channel ECG recordingA single-channel ECG will be recorded for 3 minutes while the patient is sitting at rest. The patient leans back against the chair, legs uncrossed, and arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex (CardioQVARK medical device (Electrocardiograph) issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare) P3H 2024/22855, issued on June 5, 2024). | Diagnostic test | intervention group |
Primary outcome
specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy
Time frame: 30 days after sugery starts
statistical parameter of diagnostic and prognostic accuracy of the method under study
specificity, sensitivity, prognostic significance of a positive and negative result, prognostic significance of a positive and positive result, diagnostic accuracy
Time frame: perioperative period - from the surgery starts till 30 days after surgery
statistical parameter of diagnostic and prognostic accuracy of the method under study
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 10 Feb 2026.
- BackgroundParoxysms of atrial fibrillation during planned cardiac surgery under artificial circulation / E. P. Gulyaeva-Seltsovskaya, I. Dkhif, A. A. Mols [et al.] // Bulletin of the Smolensk State Medical Academy. - 2023. - Vol. 22, No. 4. - P. 100-106. - DOI 10.37903/vsgma.2023.4.14. - EDN MIIWSU
- BackgroundChomakhidze P.Sh., Kurbanalieva N.K., Nebezhev A.A., Sedov V.P., Syrkin A.L. Modern aspects of preoperative examination in planned extracardiac interventions. Consilium Medicum. 2025;27(1): DOI: 10.26442/20751753.2025.1.203060 © CONSILIUM MEDICUM LLC, 2025
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrioventricular Block, Second and Third Degree, run by I.M. Sechenov First Moscow State Medical University.
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 3 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Peter Chomakhidze, Prof. (+79166740369, chomakhidze_p_sh@staff.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy (time frame: 30 days after sugery starts). The study lists 2 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 NCT07348991, 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 10 Feb 2026.