Health Condition 1: I499- Cardiac arrhythmia, unspecified
Conditions
Interventions
None listed
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Above 18 years of age 2) Patients with the previous history of cardiovascular disease 3) Patients with a previous history of cardiovascular disease (or) suspected (or) increased risk of cardiac arrhythmia in the setting of unexplained syncope, cryptogenic stroke or with transient symptoms of dizziness, palpitations, or chest pain 4) Enroll only In-patients who can complete for the Group A study 5) The subject is willing to sign the Informed consent form
Exclusion criteria
Exclusion criteria: 1) Patients implanted with Cardiac Implantable Electronic Device (CIED) (e.g., IPG, ICD, CRT, etc.) 2) Any high-risk patient who is already implanted or needs an implant with other life sustaining equipment during the course of study, that may interfere with the function of Cardilinq External Cardiac Monitor(ECM) prototype should be excluded as per physician discretion 3) Patients with a history of sweat allergy 4) Patients with prior evidence of skin irritation or symptoms of skin infection OR wound at any point where the ZephyrTM Bioharness chest strap will contact the subject 5) Female patients who are pregnant and breastfeeding 6) Not willing to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study to evaluate the quality of the ECG signal acquisition to assess the incidence of cardiac arrhythmia during short-term (up to 24hrs) and long-term monitoring (for 3 months), via Group A and Group B studies respectively.Timepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the patient comfort level and compliance with the prototype use while being continuously monitored for 3 months. - To assess the functionality of the prototype in acquiring ECG data for a period of 3 Months. Timepoint: 3 Months | — |
Countries
India
Contacts
Public ContactVinay Rajan
India Medtronic Pvt. Ltd.
Outcome results
None listed