To evaluate the safety and performance of Dafodil™ Pericardial Bioprosthesis in patients undergoing native/prosthetic aortic or mitral valve replacement.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/04/064961
- Lead Sponsor
- Meril Diagnostics private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 Investigator’s or heart team’s opinion would
preclude safe participation of patients in the study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method