Health Condition 1: I358- Other nonrheumatic aortic valve disorders
Conditions
Interventions
Intervention1: Surgical Aortic Valve Replacement: Surgical Aortic Valve Replacement with TTK Chitra mechanical prosthesis patients monitored for 10-15 min. of ECG monitoring.
Intervention2: Surgical
Sponsors
Fourth Frontier Technologies Pvt Ltd
Eligibility
Inclusion 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
Exclusion criteria: o Subjects 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: Group 1 - Surgical Aortic Valve Replacement with TTK Chitra mechanical prosthesis. 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
| Measure | Time frame |
|---|---|
| - 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: Group 1 - Surgical Aortic Valve Replacement with TTK Chitra mechanical prosthesis. Group 2 - Surgical Reconstruction of the Aortic Valve | — |
Countries
India
Contacts
Public ContactDr C S Hiremath MCh
Sri Sathya Sai Institute of Higher Medical Sciences (SSSIHMS)
Outcome results
None listed