Wearable external loop recorder for continuous cardiac monitoring
- Conditions
- Health Condition 1: I499- Cardiac arrhythmia, unspecified
- Registration Number
- CTRI/2020/02/023576
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method -To assess the patient comfort level and compliance with the prototype use while being continuously monitored for 3 months. <br/ ><br>-To assess the functionality of the prototype in acquiring ECG data for a period of 3 Months. <br/ ><br>Timepoint: 3 Months