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Clinical Validation of sensor based portable ECG device

Comparative Validation of SANKETLIFE PROPLUS, touch based portable ECG device with standard ECG machine to detect cardiovascular diseases in diagnosed and undiagnosed section of society: Post marketing Surveillance Study - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061589
Enrollment
3000
Registered
2024-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: I999- Unspecified disorder of circulatory system

Interventions

Control Intervention1: NIL: NIL

Sponsors

Agatsa Software Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patient above 18 years, male & female, patients visiting general OPD & Cardiac OPD of AIIMS, Diagnosed with CVD & new cases, Vulnerable group including- elderlies, Economical and social disadvantaged, refuge, migrants, homeless, physically disabled.

Exclusion criteria

Exclusion criteria: pregnant lady, lactating mother, children, age less than 18 years, terminally ill, pace maker installed, mentally disabled.

Design outcomes

Primary

MeasureTime frame
Comparative accuracy analysis of SANKETLIFE PROPLUS.Timepoint: At baseline—

Secondary

MeasureTime frame
Applicability of SANKETLIFE PROPLUS at home care.Timepoint: at baseline—

Countries

India

Contacts

Public ContactItra Singh

Agatsa Software Pvt. Ltd

itra.singh@agatsa.com07417455107

Outcome results

None listed

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