Severe Aortic Valve StenosisValvular Heart DiseaseAortic Valve Stenosis
Investigational drug(s) / intervention(s)
Hydra THV
Hydra THV: Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
Study summary
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system.
The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Participants who meet ALL of the following conditions will be included:
* Age ≥ 18 years and;
* Severe aortic stenosis with indication for aortic valve replacement in which a Hydra THV device is implanted according to the instructions for use; and
* Signed informed consent.
Exclusion Criteria:
Patients who do NOT meet ANY of the following conditions will be included:
* Express refusal by the participant to participate in the study.
* Aortic stenosis patients who are not candidates for Hydra THV device implantation or in whom implantation of this device is performed for an indication other than aortic stenosis (especially pure native aortic valve insufficiency). Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses may be included in the study.
* Participants in randomised clinical trials who have not reached the research endpoint.
* Pregnant and/or breastfeeding women.
Primary outcome measure(s)
Assessment of the success rate of implantation — 7 days Assessment of the success rate of implantation defined by:
* Absence of mortality during the procedure or within 24 hours after implantation; and
* Correct anatomical positioning of a single valve; and
* Absence of mismatch, defined as effective aortic valve area \> 0.85 cm²/m²and;
* Mean gradient \< 20 mm Hg or peak velocity \< 3 m/s and;
* Absence of moderate or severe aortic regurgitation
Success of the procedure — 7 days Composite outcome measures defined as a the absence of intra-procedural mortality or complications during implantation, such as: failure to implant the valve at the annulus level, the need to implant more than one valve (valve-in-valve implantation or implantation of a second valve due to embolisation of the first) or surgical intervention on the aortic valve due to severe aortic insufficiency or complications of the procedure.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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