Health Condition 1: I358- Other nonrheumatic aortic valve disorders
Conditions
Interventions
None listed
Sponsors
SRM Institutes for Medical Science SIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient who have undergone aortic valve replacement with Edwards Inspiris Resilia (EIR) in aortic position either of aortic stenosis/ aortic regurgitation. 2. Patient who have undergone concomitant procedure along with Aortic valve replacement with EIR. 3. Age: Above 18 years, both genders. 4. Subject undergoing redo AVR surgery due to previous mechanical/ bioprosthetic valve dysfunction/thrombosis (due to non-compliance to anti-coagulation medication) 5. Child-bearing age female patients planning pregnancy 6. Those who are willing to provide consent.
Exclusion criteria
Exclusion criteria: 1.Infective Endocarditis 2.Paediatric and Congenital Heart Disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness and safety of the Aortic Valve Model 11500A are the outcomes measured in the study.Effectiveness will be measured in terms of hemodynamic performance confirmed by Echocardiography at Core Lab (SIMS Hospital). The following parameters will be observed:Peak Velocity,Peak Gradient,Heart Rate,DVI,Acceleration,Time,Velocity Time Integral (Aortic Valve),Mean Gradient,Stroke Volume,EOA,LVOT VTI,LV Mass,IVS â?? Systole, Diastole,Posterior Valve â?? Systole,Diastole,LVIDd and LVIDs.New York Heart Association(NYHA)functional class compared to baseline.Timepoint: The subsequent follow-up visits will be made after 3 months, 1 year, and annually thereafter up to 5th year from the date of implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be measured with the following descriptive information of early rates and late lineraized rates of Structural valve deterioration,Thrombeembolism,valve thrombosis,all bleeding/ hemorrhage,major bleeding/hemorrhage,all paravalvular leak,major paravalvular leak,non-structural valve deterioration,endocarditis,all cause mortality,valve related mortality,Valve related reoperation,Explant and Haemolysis.Timepoint: The subsequent follow-up visits will be made after 3 months, 1 year, and annually thereafter up to 5th year from the date of implant. | — |
Countries
India
Contacts
Public ContactDr Bashi V V
SRM Institutes for Medical Science (SIMS)
Outcome results
None listed