Hydra Registry - Italy Experience
Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
Sahajanand Medical Technologies Limited
500 participants
Jul 1, 2023
OBSERVATIONAL
Conditions
Summary
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
Eligibility
Inclusion Criteria2
- Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team
- Ability to understand and provide informed consent for inclusion in the study
Exclusion Criteria3
- Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.
- Refusal by the patient to participate in the study
- High probability of non-adherence to required follow-ups
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Interventions
The Hydra device is self-expanding transcatheter aortic valve consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05956652