CTRI/2020/02/023187
Suspended
Phase 2
Validation study of HeartOS: Recording Electrocardiogram and Systolic Time Intervals in patients undergoing surgical replacement or repair of aortic valve - HeartOs-AVD Validation
Fourth Frontier Technologies Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: I358- Other nonrheumatic aortic valve disorders
- Sponsor
- Fourth Frontier Technologies Pvt Ltd
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •o Adolescent/Adult Subjects with a known diagnosis of AS/AI as diagnosed by a physician either clinically or by means of a diagnostic device to form the study group.
- •o Patients with any concomitant cardiac abnormalities (not critical) may also be included.
- •o Patients with co\-existing Hypertension, Diabetes Mellitus and Hypercholesterolemia can be included.
- •o Age: \> 12 years of age of both genders.
- •o Subjects admitted to inpatient for a scheduled corrective surgical Aortic Valve replacement /reconstruction and Subjects sent for a cardiac check\-up for follow up in the OPD/Clinic.
- •o Informed Consent as documented by the signature (Appendix: Assent Form (FOR Adolescents \<18y \& Informed Consent Form).
Exclusion Criteria
- •o Subjects \< 12 years 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 (renal failure, major neurological deficits, hepatic dysfunction, etc.).
- •o Pregnancy.
- •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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