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Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

ConditionsSevere Aortic Valve StenosisValvular Heart DiseaseAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The Hydra THV valve is approved for the treatment of patients with aortic stenosis. Basically, patients will be eligible for inclusion in this clinical scenario, according to the instructions for use of the device.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Hydra THV

    Device

    Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Hydra Transcatheter Heart Valve (THV)1 intervention

Trial outcomes

Primary outcomes

1

Assessment of the success rate of implantation

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

Time frame
7 days
2

Success of the procedure

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.

Time frame
7 days

Secondary outcomes

1

All cause mortality

Incidence of all cause mortality

Time frame
7 days
2

All cause mortality

Incidence of all cause mortality

Time frame
30 days
3

All cause mortality

Incidence of all cause mortality

Time frame
12 months
4

Cardiovascular mortality

Incidence of cardiovascular mortality

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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