CTRI/2020/02/023170
Active, not recruiting
Phase 2
Validation study of HeartOS: Recording Electrocardiogram and Systolic Time Intervals in patients with Congenital Heart Defect
Fourth Frontier Technologies Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fourth Frontier Technologies Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •o Subjects admitted to inpatient for a scheduled corrective surgical or percutaneous intervention or subjects sent for a cardiac check\-up in the OPD/Clinic.
- •o Age: \> 6 months of age of both genders.
- •o Pediatric/Adult Subjects with a known diagnosis of CHD (including ASD, VSD, PDA, TOF and Congenital Structural Valve Defects (including patients with Pulmonic and Aortic stenosis scheduled for Balloon Dilatation) as diagnosed by a physician either clinically or by means of a diagnostic device to form the study group.
- •o Pediatric/Adult patients without any underlying cardiac disorders/ medical conditions and cleared to be healthy by qualified medical personnel to form the control group that will be matched for both age and gender with the study group.
- •o Informed Consent as documented by the signature (Appendix: Assent Form (FOR CHILDREN 7 to \< 18 years of age \& Informed Consent Form).
Exclusion Criteria
- •o Subjects \< 6 months of age.
- •o Subjects with a critical underlying cardiac problem, or obstructive left\-sided heart lesions.
- •o Subjects on a ventilator or any other kind of life support system.
- •o Subjects assessed to be in a serious or life\-threatening situation due to any cause e.g. significant concomitant disease states (e.g., renal failure, major neurological deficits, hepatic dysfunction, etc.).
- •o Known or suspected non\-compliance, drug or alcohol abuse.
- •o Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Outcomes
Primary Outcomes
Not specified
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