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Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Monitor.

NCT04204330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2024-10-08

No results posted yet for this study

Summary

This interventional prospective multicenter nonrandomized clinical and epidemiological study is the first Russian study aimed at evaluating the effectiveness of a single-lead electrocardiography device (CardioQVARK) in screening for atrial fibrillation in primary health care.

Conditions

Interventions

DEVICE

CardioQvark cardiac monitor and software, single-lead ECG

Registration certificate for the medical device No. РЗН 2019/8124 dated February 15, 2019. Product form: phone case. Way of applying: 1. Download the CardioQVARK mobile application; create a profile. 2. Fill out the questionnaire: * age; * date of birth; * sex; * weight; * height; * blood type; * eye color; * hair color; * occupation; * town; * alcohol consumption; * tobacco use; * overeating; * insufficient sleep; * hypertension; * type 2 diabetes; * pacemaker; * the 10th revision of the International Classification of Diseases (ICD-10) code; * medicines. 3. Place index fingers on sensors that are on the case's backside and record 1-lead ECG of up to 3 minutes duration. Recorded parameters: * time parameters of the ECG intervals (RR, P, PR, QRS, QT, QTc); * abnormal rhythms; * heart rate variability; * additional function - blood pressure and blood sugar diary. All recorded and calculated parameters are passed to the server.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Philipp Kopylov, Professor · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
96 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2024-10-03
Completion
2024-10-03

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204330 on ClinicalTrials.gov