Hydra Registry - Italy Experience
Reason given: Withdrawn (No Participants Enrolled)
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Trial details
- Who runs it
- Sahajanand Medical Technologies Limited
- Trial code
- NCT05956652
- Record updated
- 18 August 2026
- Original description
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.Read full original descriptionShow less
Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
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.
Inclusion: 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: 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.