NCT04204330 - Federal Cardiomonitoring System. Determination of the Efficiency of a Single-lead ECG Monitor. | Biotech Hunter

Enrollment

5,000

Participants

Timeline

Start Date

March 4, 2019

Primary Completion Date

October 3, 2024

Study Completion Date

October 3, 2024

Conditions

Atrial Fibrillation

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."

Trial Locations (12)

141000

"Branch office of State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

141005

"Clinic №1, State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

"Clinic №4, State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

141032

"State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

141033

"Clinic №2, State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

141035

"State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

141036

"Branch of State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

141044

"Branch office of State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

"State Budgetary Healthcare Institution of Moscow Region Mytishchi City Clinical Hospital", Mytishchi

All Listed Sponsors

lead

I.M. Sechenov First Moscow State Medical University

OTHER