Observational study on the Hydra TAVI System for aortic valve stenosis in Italy
Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
This study is testing how well the Hydra heart valve replacement system works for people in Italy with severe aortic valve narrowing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Sahajanand Medical Technologies Limited Industry-sponsored |
| Locations | 4 sites (Brescia and 3 other locations) |
| Trial ID | NCT05956652 on ClinicalTrials.gov |
What this trial studies
The Hydra Registry - Italy Experience is a multicenter observational study that aims to collect clinical, procedural, and follow-up data regarding the Hydra Transcatheter Aortic Valve Implantation (TAVI) System in patients with severe aortic stenosis. The study evaluates the safety and efficacy of the Hydra device and assesses clinical outcomes over short, medium, and long-term periods, extending up to five years. Patients with symptomatic native aortic valve stenosis or degenerated bioprosthesis will be included, with a focus on understanding the quality of treatment provided by the Hydra device.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe symptomatic native aortic valve stenosis who are deemed suitable for the TAVI procedure by a Heart Team.
Not a fit: Patients with contraindications to TAVI, such as intracardiac mass or endocarditis, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with severe aortic stenosis by providing valuable data on the effectiveness of the Hydra TAVI System.
How similar studies have performed: Other studies on TAVI systems have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brescia and 3 other locations
- Fondazione Poliambulanza Istituto — Brescia, Italy (Recruiting)
- Montevergine Clinic, Mercogliano, Italy — Mercogliano, Italy (Recruiting)
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Italy (Not_yet_recruiting)
- Università degli studi di Padova — Padova, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Dr. Angelo Cioppa — Montevergine Clinic, Mercogliano, Italy
- Study coordinator: Dr. Angelo Cioppa
- Email: emodinamica@clinicamontevergine.it
- Phone: +390825705131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.