HeartOs Cardiovascular Validation study in Aortic Valve Defect (AVD) monitoring
- Conditions
- Health Condition 1: I358- Other nonrheumatic aortic valve disorders
- Registration Number
- CTRI/2020/02/023187
- Lead Sponsor
- Fourth Frontier Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
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).
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To draw a comparison of the STIs across the two groups of patients (matched for aortic annulus diameter and hemodynamic indices) wherein each category receives one of the three different prosthetic valves: <br/ ><br>Group 1 - Surgical Aortic Valve Replacement with TTK Chitra mechanical prosthesis. <br/ ><br>Group 2 - Surgical Reconstruction of the Aortic ValveTimepoint: The study subjects will have the measurements taken multiple times, once immediately/24-48 hours prior to therapeutic intervention, once immediately or 48-72 hrs post-intervention or prior to discharge, 3 months and 6-12 months post-intervention.
- Secondary Outcome Measures
Name Time Method - To investigate for a correlation with the changes in STIs in comparison to the changes in the flow gradients (measured by Echo) across the newly replaced / reconstructed valves, post valve replacement/ reconstruction.Timepoint: To draw a comparison of the STIs across the two groups of patients (matched for aortic annulus diameter and hemodynamic indices) wherein each category receives one of the three different prosthetic valves: <br/ ><br>Group 1 - Surgical Aortic Valve Replacement with TTK Chitra mechanical prosthesis. <br/ ><br>Group 2 - Surgical Reconstruction of the Aortic Valve