RecruitingNot Applicable

Hydra Registry - Italy Experience

Italy500 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cardiovascular mortality

Timeframe: 30 days

Trial details

NCT IDNCT05956652

SponsorSahajanand Medical Technologies Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-07-31

Contact for this trial

Dr. Angelo Cioppa

+390825705131 emodinamica@clinicamontevergine.it

View on ClinicalTrials.gov More Aortic Valve Stenosis trials