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NCT05956652
Hydra Registry - Italy Experience
Conditions: Aortic Valve Stenosis
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Sponsor: Sahajanand Medical Technologies Limited
Location: Fondazione Poliambulanza Istituto Brescia
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT05956652). StuddyBuddy aggregates publicly available trial information.