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Hydra Registry - Italy Experience

RECRUITINGSponsored by Sahajanand Medical Technologies Limited
Actively Recruiting
SponsorSahajanand Medical Technologies Limited
Started2023-07-01
Est. completion2025-07-31
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05956652

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

Age: 18 Years – 99 YearsHealthy volunteers accepted
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

Conditions2

Aortic Valve StenosisHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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