A follow up study to evaluate the safety and effectiveness of tissue valve (aortic) among Indian patients
Not Applicable
- Conditions
- Health Condition 1: I358- Other nonrheumatic aortic valve disorders
- Registration Number
- CTRI/2022/08/044557
- Lead Sponsor
- SRM Institutes for Medical Science SIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
1.Infective Endocarditis
2.Paediatric and Congenital Heart Disease
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method