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Validation of ambulatory cardiac rhythm monitoring solution - Vigo Heart

A prospective Study of Continuous ECG Monitoring with Wearable Wireless Patch-Based Solution -Vigo Heart Compared with a Conventional Ambulatory ECG Holter - VC-VHT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/04/051734
Enrollment
120
Registered
2023-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: I499- Cardiac arrhythmia, unspecified

Interventions

None listed

Sponsors

Vigocare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years of both the genders, Patient capable of giving informed consent, able to comply with long term continuous monitoring with Vigo Heart patch and Holter,Suspected arrhythmia related signs, palpitations of uncertain etiology, pre syncope of uncertain etiology, patient at risk of arrhythmia after myocardial infraction, cognitive cardiac failure or valvular heart disease

Exclusion criteria

Exclusion criteria: Age less than 128 years, have known skin allergies to adhesive and psoriasis, patients with any dermatitis or infected skin or skin with burns on chest area, asternal or thoracic incision that extends under the patch within 3 months from the date of enrollments, patient with chest injuries, intra cerebral bleed in medical history,end stage renal disease, pregnant and lactating women, infective endo condition, anticipated to be exposed to high frequency equipment MRI and CT-Scans, Stroke induced by trauma, infection surgery procedures, Dementia, mental disorders, suspected non-compliance of the study, enrolled patients with connectivity issues, lead off, data loss or analyzable data <60%

Design outcomes

Primary

MeasureTime frame
1)To compare the diagnostic yield to detect arrythmia of conventional ambulatory holters with Vigo heart single lead corresponding to lead 2 of ECG, 2)To study the compliance and usability of Vigo heart solution by the patient during the monitoring period, 3) To Study the accuracy and efficiency of clinical analysis and clarity of the recorded signals by the physicians Timepoint: 6 months

Secondary

MeasureTime frame
By validation of this solution, we can provide Long term ambulatory cardiac rhythm monitoring to the patient without disturbing their daily routines. The health care professionals can take clinical decisions at an appropriate time even before the critical event occurs as they have the report available in fastest time possibleTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Sowjanya Patibandla

ESIC Medical college and Hospital

drrajivb85@gmail.com

Outcome results

None listed

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