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Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

NCT07566624 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-05

No results posted yet for this 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.

Conditions

  • Severe Aortic Valve Stenosis
  • Valvular Heart Disease
  • Aortic Valve Stenosis

Interventions

DEVICE

Hydra THV

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

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-01-01
Completion
2029-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566624 on ClinicalTrials.gov