Clinical Trial

Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG

Not Yet Recruiting
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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. 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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-10.
Trial Details
NCT Number NCT07348991
Lead Sponsor I.M. Sechenov First Moscow State Medical University
Conditions Atrial Fibrillation, Atrioventricular Block, Second and Third Degree, Sinus Node Dysfunction, Ventricular Tachycardia (VT), Ventricular Fibrillation
Enrollment 300 participants
Start Date 2026-12-31
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-10