Study on the efficacy and safety of Hydra valve
Not Applicable
- Conditions
- Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
- Registration Number
- CTRI/2024/05/067666
- Lead Sponsor
- Sahajanand Medical Technologies Limited (SMT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients affected by symptomatic severe aortic stenosis (NYHA class = II) eligible for TAVI procedure as per local Heart Team evaluation
2. Full understanding and willing to provide informed consent to study enrolment
Exclusion Criteria
1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
2. Refusal to provide informed consent to study enrolment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary safety endpoint: Cardiovascular mortality <br/ ><br>Primary performance endpoint: Device successTimepoint: 30 days
- Secondary Outcome Measures
Name Time Method