Health Condition 1: null- Undergoing Holter monitoring for the diagnosis of suspected cardiac arrhythmias/conduction disturbances. Health Condition 2: R009- Unspecified abnormalities of heartbeat
Conditions
Interventions
Control Intervention1: Ambulatory Holter Monitor: 12-lead ECG holter monitoring for 24 hours
Frequency - only once
Duration - 24 hours
Sponsors
Monitra Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 - Is female or male, 18 years of age or older. 2 - Undergoing Holter monitoring for the diagnosis of suspected cardiac arrhythmias/conduction disturbances. 3 - Is not participating in another clinical study that may confound the results of this study
Exclusion criteria
Exclusion criteria: 1 - Any known skin allergy or sensitivity to adhesive material. 2 - Patients with cardiac pacing devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare capture of cardiac arrhythmias and heart blocks on the study device with 24 hours Holter monitoring.Timepoint: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the following between the study device and Holter monitoring after an intended wear time of 24 hours. 1 - Patient experience of the device attachment to skin, 2 - Skin rash/irritation with the device, 3 - ECG Technicians rating on ease-of-use during device deployment. The following will be assessed at the end of 48 hours. 1 - Patient comfort with device during daily activities.Timepoint: 48 hours | — |
Countries
India
Contacts
Public ContactDr Daljeet Saggu
Care Hospitals
Outcome results
None listed