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Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

Study acronym: HYSPANIA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 2 to 3 Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 3 of 46 entries · Publications: details revised at 5 of 5 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 46 entries
    • Publications: details revised at 5 of 5 entries
  2. Minor Study sites: 1 to 2v3
  3. Notable Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jun 1, 2026 to Jul 7, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2026 to Jul 7, 2026
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07566624
Lead Sponsor Fundación EPIC
Conditions Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov