Health Condition 1: Z018- Encounter for other specified special examinations
Conditions
Interventions
Intervention1: CardioSAM-DRSMARTHEART ECG MACHINE: Standard Simultaneous 12 channel Resting Digital ECG is used to take ECG on same day.
Control Intervention1: 12 Channel ECG: GE MAC 1200 ST
Sponsors
Samtech Devices India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of age between 18 to 60. 2.For whom the Investigator considers that the compliance will be correct. 3.Cooperating, informed of the need and duration of the study, and ready to comply with protocol procedures. 4.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
Exclusion criteria
Exclusion criteria: 1.Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure. 2.Known sensitivity to the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study would be the efficacy of the IP which will be assessed by assessing the ECG results from Investigational Product and comparative productTimepoint: The primary endpoint of the study would be the efficacy of the IP which will be assessed by assessing the ECG results from Investigational Product and comparative product on vist 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary end-points of this study would be safety and adverse eventsTimepoint: Visit 2 | — |
Countries
India
Contacts
Public ContactSuresh Jeevarathinam
Innovitae Clinical Research Services Pvt Ltd
Outcome results
None listed