Observational Real World National Registry of Dafodil.
Phase 4
- Conditions
- Health Condition 1: I350- Nonrheumatic aortic (valve) stenosisHealth Condition 2: I342- Nonrheumatic mitral (valve) stenosis
- Registration Number
- CTRI/2022/07/044021
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion Criteria:
1. Patients implanted with Dafodil™ Pericardial Bioprosthesis or with its subsequent advanced versions.
2. Patients or LAR (Legally Acceptable Representative) has given written informed consent for participation prior to enrolment.
3. Patient is willing to undergo all study procedures and follow-up requirements.
Exclusion Criteria
NI
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate Valve-related adverse events compared with OPC. <br/ ><br>The following valve-related adverse events will be evaluated: <br/ ><br>oThromboembolism <br/ ><br>oValve Thrombosis <br/ ><br>o Major Haemorrhage <br/ ><br>o Major Paravalvular leak <br/ ><br>o Endocarditis <br/ ><br>Timepoint: greater than 30 days to 3 year
- Secondary Outcome Measures
Name Time Method