| NCT ID | NCT05956652 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahajanand Medical Technologies Limited |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-07-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Dr. Angelo Cioppa
PRINCIPAL INVESTIGATOR
Montevergine Clinic, Mercogliano, Italy
Frequently Asked Questions
Who can join the NCT05956652 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05956652 currently recruiting?
Yes, NCT05956652 is actively recruiting participants. Contact the research team at emodinamica@clinicamontevergine.it for enrollment information.
Where is the NCT05956652 trial being conducted?
This trial is being conducted at Brescia, Italy, Mercogliano, Italy, Milan, Italy, Padova, Italy.
Who is sponsoring the NCT05956652 clinical trial?
NCT05956652 is sponsored by Sahajanand Medical Technologies Limited. The principal investigator is Dr. Angelo Cioppa at Montevergine Clinic, Mercogliano, Italy. The trial plans to enroll 500 participants.