Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: surgical aortic valve replacement: surgical aortic valve replacement will be performed by using Dafodilââ??¢ Pericardial Bioprosthesis or its subsequent advanced version the study du
Sponsors
EPIC Hospital A Unit of Vatsalya Healthcare LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients whose valvular disease is sufficiently advanced to warrant replacement of their natural/prosthetic aortic or mitral valve with Dafodil pericardial bioprosthesis or its subsequent advanced version. 2. Patients who are willing to undergo all protocol specific study procedures and follow-up requirements. 3. Patient or his/her Legally Acceptable Representative (LAR) has been informed about the nature of the registry and informed consent for study participation has been obtained from the patient or LAR, as per applicable local requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study 2. Any condition, which, in Investigatorââ?¬•s or heart teamââ?¬•s opinion would preclude safe participation of patients in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the composite of: All-cause mortality - Thromboembolism - Valve thrombosis [2,3] - Major haemorrhage - Major valvular/paravalvular leak - EndocarditisTimepoint: Time Frame - 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality Cardiac death Valve related mortality Sudden Unexplained death Valve thrombosis Major Valvular/Paravalvular Leak Acute Kidney Injury Bleeding Endocarditis Structural valve deterioration Non-structural dysfunction Thromboembolism Re-interventionTimepoint: 30 days 3 months 6 months 1 year 2 years 3 years 4 years and 5 years | — |
Countries
India
Contacts
Public ContactDr Naman Shastri
EPIC Hospital (A Unit of Vatsalya Healthcare LLP)
Outcome results
None listed