Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation (HYSPANIA)

4. august 2026 oppdatert av: Fundación EPIC

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Spania
      • Fuencarral-El Pardo, Spania, 28046
        • Rekruttering
        • Hospital Universitario La Paz
      • Santiago de Compostela, Spania, 15706
        • Rekruttering
        • Hospital Clínico Universitario de Santiago

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Hydra Transcatheter Heart Valve (THV)
Enhet: Hydra THV
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of the success rate of implantation
Tidsramme: 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
7 days
Success of the procedure
Tidsramme: 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.
7 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Kardiovaskulær dødelighet
Tidsramme: 12 måneder
Forekomst av kardiovaskulær dødelighet
12 måneder
All cause mortality
Tidsramme: 7 days
Incidence of all cause mortality
7 days
All cause mortality
Tidsramme: 30 days
Incidence of all cause mortality
30 days
All cause mortality
Tidsramme: 12 months
Incidence of all cause mortality
12 months
Cardiovascular mortality
Tidsramme: 7 days
Incidence of cardiovascular mortality
7 days
Cardiovascular mortality
Tidsramme: 30 days
Incidence of cardiovascular mortality
30 days
Stroke
Tidsramme: 7 days
Incidence of Stroke
7 days
Stroke
Tidsramme: 30 days
Incidence of Stroke
30 days
Stroke
Tidsramme: 12 months
Incidence of Stroke
12 months
Stroke with disabling
Tidsramme: 7 days
Incidence of Stroke with disabling
7 days
Stroke with disabling
Tidsramme: 30 days
Incidence of Stroke with disabling
30 days
Stroke with disabling
Tidsramme: 12 months
Incidence of Stroke with disabling
12 months
Stroke with non disabling
Tidsramme: 7 days
Incidence of Stroke with non disabling
7 days
Stroke with non disabling
Tidsramme: 30 days
Incidence of Stroke with non disabling
30 days
Stroke with non disabling
Tidsramme: 12 months
Incidence of Stroke with non disabling
12 months
Acute myocardial infarction
Tidsramme: 7 days
Incidence of acute myocardial infarction
7 days
Acute myocardial infarction
Tidsramme: 30 days
Incidence of acute myocardial infarction
30 days
Acute myocardial infarction
Tidsramme: 12 months
Incidence of acute myocardial infarction
12 months
Coronary occlusion
Tidsramme: 7days
Incidence of coronary occlusion
7days
Coronary occlusion
Tidsramme: 30 days
Incidence of coronary occlusion
30 days
Coronary occlusion
Tidsramme: 12 months
Incidence of coronary occlusion
12 months
Haemorrhagic complications
Tidsramme: 7 days
Incidence of haemorrhagic complications
7 days
Haemorrhagic complications
Tidsramme: 30 days
Incidence of haemorrhagic complications
30 days
Haemorrhagic complications
Tidsramme: 12 months
Incidence of haemorrhagic complications
12 months
Vascular complications
Tidsramme: 7 days
Incidence of vascular complications
7 days
Vascular complications
Tidsramme: 30 days
Incidence of vascular complications
30 days
Vascular complications
Tidsramme: 12 Months
Incidence of vascular complications
12 Months
Acute renal failure
Tidsramme: 7 days
Incidence of Acute renal failure
7 days
Acute renal failure
Tidsramme: 30 days
Incidence of Acute renal failure
30 days
Acute renal failure
Tidsramme: 12 months
Incidence of Acute renal failure
12 months
Conduction disturbances
Tidsramme: 7 days
Incidence of conduction disturbances
7 days
Conduction disturbances
Tidsramme: 30 days
Incidence of conduction disturbances
30 days
Conduction disturbances
Tidsramme: 12 months
Incidence of conduction disturbances
12 months
Arrhythmias
Tidsramme: 7 days
Incidence of Arrhythmias
7 days
Arrhythmias
Tidsramme: 30 days
Incidence of Arrhythmias
30 days
Arrhythmias
Tidsramme: 12 months
Incidence of Arrhythmias
12 months
Implantation of a new permanent pacemaker
Tidsramme: 7 days
Incidence of Implantation of a new permanent pacemaker
7 days
Implantation of a new permanent pacemaker
Tidsramme: 30 days
Incidence of Implantation of a new permanent pacemaker
30 days
Implantation of a new permanent pacemaker
Tidsramme: 12 months
Incidence of Implantation of a new permanent pacemaker
12 months
Combined safety event at 30 days defined by Valve Academic Research Consortium 3 (VARC-3) criteria
Tidsramme: 30 days
Proportion of patients with freedom from: all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device.
30 days
New York Heart Association (NYHA)
Tidsramme: 7 days
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
7 days
New York Heart Association (NYHA)
Tidsramme: 30 days
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
30 days
New York Heart Association (NYHA)
Tidsramme: 12 months
Proportion of patients with modification of NYHA before the procedure and its modification after the procedure
12 months
Echocardiographic Valve Dysfunction Assessment
Tidsramme: 7 days

Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction:

Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency
7 days
Echocardiographic Valve Dysfunction Assessment
Tidsramme: 30 days

Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction:

Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency
30 days
Echocardiographic Valve Dysfunction Assessment
Tidsramme: 12 months

Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction:

Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fundación EPIC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. juli 2026

Primær fullføring (Antatt)

1. januar 2029

Studiet fullført (Antatt)

1. februar 2029

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

27. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • rEpic22-HYSPANIA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere