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Validation of ambulatory cardiac rhythm monitoring solution - Vigo Heart

Not Applicable
Conditions
Health Condition 1: I499- Cardiac arrhythmia, unspecified
Registration Number
CTRI/2023/04/051734
Lead Sponsor
Vigocare Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
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

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%

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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