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Withdrawn NCT05956652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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05956652). StuddyBuddy aggregates publicly available trial information.