Hydra Registry - Italy Experience
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSahajanand Medical Technologies Limited
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hydra Transcatheter Aortic Valve System
Treatment groups
No treatment groups listed
Locations
4Fondazione Poliambulanza Istituto25124, Brescia Italy
Montevergine Clinic, Mercogliano, Italy83013, Mercogliano Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio20157, Milan Italy
Università degli studi di Padova35122, Padova Italy
Sponsors and collaborators
Sahajanand Medical Technologies Limited
Lead sponsor
Clinica Di Montevergine
Collaborator
Source ClinicalTrials.gov