CTRI/2024/05/067666
Not yet recruiting
未知
Prospective observational study on the efficacy and safety of Hydra transcatheter aortic valve - AIIMS Hydra Registry - NI
Sahajanand Medical Technologies Limited (SMT)0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
- Sponsor
- Sahajanand Medical Technologies Limited (SMT)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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