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

27. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Kardiovaskulær dødelighed
Tidsramme: 12 måneder
Forekomst af kardiovaskulær dødelighed
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundación EPIC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • rEpic22-HYSPANIA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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