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Evaluation of ECG-AI Device Performance Using Multiple ECG Devices

A multicenter study to demonstrate compatibility of ECG-AI acress 12-Lead ECG devices - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098910
Enrollment
1000
Registered
2025-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Anumana Inc.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult subjects (age 18 or older)

Exclusion criteria

Exclusion criteria: 1. No subject consent obtained 2. Open chest wounds or recent surgery to the chest or abdomen (less than 30 days) 3. Absence of any limb that would require modification of standard lead placement

Design outcomes

Primary

MeasureTime frame
1. Mean absolute error in AI scores (continuous) between pairs of native ECGs. 2. Mean absolute error in AI scores (continuous) between native and transformed ECGs.Timepoint: Baseline Vist 1

Secondary

MeasureTime frame
MAE & cross-correlation between pairs of native ECGsTimepoint: Baseline visit 1;MAE & cross-correlation between native ECGs & transformed ECGs.Timepoint: Baseline visit 1;Concordance of AI binary outputs (sensitivity, specificity) between pairs of native ECGs against Echo-derived or clinical history labels.Timepoint: Baseline visit 1;Concordance of AI binary outputs (sensitivity, specificity) between native & transformed ECGs against Echo-derived or clinical history labels.Timepoint: Baseline visit 1

Countries

India

Contacts

Public ContactDr Bhargav Bhongiri

Syncorp Health Pvt. Ltd.

bhargav.b@syncorphealth.com9000518175

Outcome results

None listed

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