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

4 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assessment of the success rate of implantation
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Kardiovaskulär dödlighet
Tidsram: 12 månader
Förekomst av kardiovaskulär dödlighet
12 månader
All cause mortality
Tidsram: 7 days
Incidence of all cause mortality
7 days
All cause mortality
Tidsram: 30 days
Incidence of all cause mortality
30 days
All cause mortality
Tidsram: 12 months
Incidence of all cause mortality
12 months
Cardiovascular mortality
Tidsram: 7 days
Incidence of cardiovascular mortality
7 days
Cardiovascular mortality
Tidsram: 30 days
Incidence of cardiovascular mortality
30 days
Stroke
Tidsram: 7 days
Incidence of Stroke
7 days
Stroke
Tidsram: 30 days
Incidence of Stroke
30 days
Stroke
Tidsram: 12 months
Incidence of Stroke
12 months
Stroke with disabling
Tidsram: 7 days
Incidence of Stroke with disabling
7 days
Stroke with disabling
Tidsram: 30 days
Incidence of Stroke with disabling
30 days
Stroke with disabling
Tidsram: 12 months
Incidence of Stroke with disabling
12 months
Stroke with non disabling
Tidsram: 7 days
Incidence of Stroke with non disabling
7 days
Stroke with non disabling
Tidsram: 30 days
Incidence of Stroke with non disabling
30 days
Stroke with non disabling
Tidsram: 12 months
Incidence of Stroke with non disabling
12 months
Acute myocardial infarction
Tidsram: 7 days
Incidence of acute myocardial infarction
7 days
Acute myocardial infarction
Tidsram: 30 days
Incidence of acute myocardial infarction
30 days
Acute myocardial infarction
Tidsram: 12 months
Incidence of acute myocardial infarction
12 months
Coronary occlusion
Tidsram: 7days
Incidence of coronary occlusion
7days
Coronary occlusion
Tidsram: 30 days
Incidence of coronary occlusion
30 days
Coronary occlusion
Tidsram: 12 months
Incidence of coronary occlusion
12 months
Haemorrhagic complications
Tidsram: 7 days
Incidence of haemorrhagic complications
7 days
Haemorrhagic complications
Tidsram: 30 days
Incidence of haemorrhagic complications
30 days
Haemorrhagic complications
Tidsram: 12 months
Incidence of haemorrhagic complications
12 months
Vascular complications
Tidsram: 7 days
Incidence of vascular complications
7 days
Vascular complications
Tidsram: 30 days
Incidence of vascular complications
30 days
Vascular complications
Tidsram: 12 Months
Incidence of vascular complications
12 Months
Acute renal failure
Tidsram: 7 days
Incidence of Acute renal failure
7 days
Acute renal failure
Tidsram: 30 days
Incidence of Acute renal failure
30 days
Acute renal failure
Tidsram: 12 months
Incidence of Acute renal failure
12 months
Conduction disturbances
Tidsram: 7 days
Incidence of conduction disturbances
7 days
Conduction disturbances
Tidsram: 30 days
Incidence of conduction disturbances
30 days
Conduction disturbances
Tidsram: 12 months
Incidence of conduction disturbances
12 months
Arrhythmias
Tidsram: 7 days
Incidence of Arrhythmias
7 days
Arrhythmias
Tidsram: 30 days
Incidence of Arrhythmias
30 days
Arrhythmias
Tidsram: 12 months
Incidence of Arrhythmias
12 months
Implantation of a new permanent pacemaker
Tidsram: 7 days
Incidence of Implantation of a new permanent pacemaker
7 days
Implantation of a new permanent pacemaker
Tidsram: 30 days
Incidence of Implantation of a new permanent pacemaker
30 days
Implantation of a new permanent pacemaker
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 12 months
Proportion of patients with modification of NYHA before the procedure and its modification after the procedure
12 months
Echocardiographic Valve Dysfunction Assessment
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Fundación EPIC

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 juli 2026

Primärt slutförande (Beräknad)

1 januari 2029

Avslutad studie (Beräknad)

1 februari 2029

Studieregistreringsdatum

Först inskickad

27 april 2026

Först inskickad som uppfyllde QC-kriterierna

27 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • rEpic22-HYSPANIA

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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