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A research study to check the feasibility of contineous ECG monitoring at home using a wearable ECG Device

Continuous home based ECG measurement- A clinical validation study of Biocalculus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/01/017347
Enrollment
250
Registered
2019-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z018- Encounter for other specified special examinations

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Waferchips Techno solutions Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants who are 18 years or above 2.Either gender 3.Willing to consent and wear the device continuously for 72 hours

Exclusion criteria

Exclusion criteria: 1.Critically ill patients. 2.Patients diagnosed with rhythm disorders 3.Participants who in the opinion of the investigator may not be co-operative or otherwise not eligible for the study.

Design outcomes

Primary

MeasureTime frame
1.To study the feasibility of Biocalculus® device for continuous home based ECG measurement.Timepoint: 72 hours—

Secondary

MeasureTime frame
1.To study the compliance of particpants towards the use of Biocalulus device 2.To study the ECG changes among these participants 3.To study the agreement between ECG measured by Biocalculus with the standard ECG machine.Timepoint: 72 hours—

Countries

India

Contacts

Public ContactDr Vikneshwaran G

Narayana Hrudayalaya Ltd

vikneswaran.g.dr@narayanahealth.org

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026