Validation of a device to monitor heart rhythm
- Conditions
- Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter
- Registration Number
- CTRI/2023/02/050155
- Lead Sponsor
- Turtle Shell Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Adult patients above 18 years of age either in OPD or admitted in hospital
Patients referred by PI for either standard ECG monitoring or continuous ECG monitoring using holter device or ECG patch
Weight between 40kg to 120 kgs
They are able and willing to provide written informed consent
Weight below 40 kgs and above 120 kgs
Currently pregnant
Have any condition that could interfere with the subjects ability to tolerate Holter monitor or the ECG patch
Exhibit injuries, deformities, other abnormalities or skin condition that, in the opinion of the investigator, may prevent proper ECG patch and Holter or ECG machine application and functioning
Level of agitation or non-compliance too high to enroll in opinion of PI
Needs the use of equipments whose operation can interfere with Dozeeâ??s signal
A significant medical condition in the judgment of the investigator, which may compromise the study testing procedures
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method