Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation (HYSPANIA)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: FUNDACION EPIC
- Número de teléfono: 0034987876135
- Correo electrónico: iepic@fundacionepic.org
Copia de seguridad de contactos de estudio
- Nombre: RAUL MORENO GOMEZ, MD, PhD
- Número de teléfono: 0034917277000
- Correo electrónico: raulmorenog@hotmail.com
Ubicaciones de estudio
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-
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Aravaca, España, 28040
- Reclutamiento
- Hospital Clínico San Carlos
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Barcelona, España, 08041
- Reclutamiento
- Hospital de la Santa Creu i Sant Pau
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Fuencarral-El Pardo, España, 28046
- Reclutamiento
- Hospital Universitario La Paz
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L'Hospitalet de Llobregat, España, 08907
- Reclutamiento
- Hospital Universitari de Bellvitge
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Salamanca, España, 37007
- Reclutamiento
- Hospital Universitari de Salamanca
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Santiago de Compostela, España, 15706
- Reclutamiento
- Hospital Clínico Universitario de Santiago
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Seville, España, 41013
- Reclutamiento
- Hospital Universitario Virgen del Rocio
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Toledo, España, 45007
- Reclutamiento
- Hospital General Universitario de Toledo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_ONLY
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Hydra Transcatheter Heart Valve (THV)
|
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of the success rate of implantation
Periodo de tiempo: 7 days
|
Assessment of the success rate of implantation defined by:
|
7 days
|
|
Success of the procedure
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
All cause mortality
Periodo de tiempo: 7 days
|
Incidence of all cause mortality |
7 days
|
|
All cause mortality
Periodo de tiempo: 30 days
|
Incidence of all cause mortality |
30 days
|
|
All cause mortality
Periodo de tiempo: 12 months
|
Incidence of all cause mortality |
12 months
|
|
Cardiovascular mortality
Periodo de tiempo: 7 days
|
Incidence of cardiovascular mortality |
7 days
|
|
Cardiovascular mortality
Periodo de tiempo: 30 days
|
Incidence of cardiovascular mortality |
30 days
|
|
Cardiovascular mortality
Periodo de tiempo: 12 months
|
Incidence of cardiovascular mortality |
12 months
|
|
Stroke
Periodo de tiempo: 7 days
|
Incidence of Stroke |
7 days
|
|
Stroke
Periodo de tiempo: 30 days
|
Incidence of Stroke |
30 days
|
|
Stroke
Periodo de tiempo: 12 months
|
Incidence of Stroke |
12 months
|
|
Stroke with disabling
Periodo de tiempo: 7 days
|
Incidence of Stroke with disabling |
7 days
|
|
Stroke with disabling
Periodo de tiempo: 30 days
|
Incidence of Stroke with disabling |
30 days
|
|
Stroke with disabling
Periodo de tiempo: 12 months
|
Incidence of Stroke with disabling |
12 months
|
|
Stroke with non disabling
Periodo de tiempo: 7 days
|
Incidence of Stroke with non disabling |
7 days
|
|
Stroke with non disabling
Periodo de tiempo: 30 days
|
Incidence of Stroke with non disabling |
30 days
|
|
Stroke with non disabling
Periodo de tiempo: 12 months
|
Incidence of Stroke with non disabling |
12 months
|
|
Acute myocardial infarction
Periodo de tiempo: 7 days
|
Incidence of acute myocardial infarction |
7 days
|
|
Acute myocardial infarction
Periodo de tiempo: 30 days
|
Incidence of acute myocardial infarction |
30 days
|
|
Acute myocardial infarction
Periodo de tiempo: 12 months
|
Incidence of acute myocardial infarction |
12 months
|
|
Coronary occlusion
Periodo de tiempo: 7days
|
Incidence of coronary occlusion |
7days
|
|
Coronary occlusion
Periodo de tiempo: 30 days
|
Incidence of coronary occlusion |
30 days
|
|
Coronary occlusion
Periodo de tiempo: 12 months
|
Incidence of coronary occlusion |
12 months
|
|
Haemorrhagic complications
Periodo de tiempo: 7 days
|
Incidence of haemorrhagic complications |
7 days
|
|
Haemorrhagic complications
Periodo de tiempo: 30 days
|
Incidence of haemorrhagic complications |
30 days
|
|
Haemorrhagic complications
Periodo de tiempo: 12 months
|
Incidence of haemorrhagic complications |
12 months
|
|
Vascular complications
Periodo de tiempo: 7 days
|
Incidence of vascular complications |
7 days
|
|
Vascular complications
Periodo de tiempo: 30 days
|
Incidence of vascular complications |
30 days
|
|
Vascular complications
Periodo de tiempo: 12 Months
|
Incidence of vascular complications |
12 Months
|
|
Acute renal failure
Periodo de tiempo: 7 days
|
Incidence of Acute renal failure |
7 days
|
|
Acute renal failure
Periodo de tiempo: 30 days
|
Incidence of Acute renal failure |
30 days
|
|
Acute renal failure
Periodo de tiempo: 12 months
|
Incidence of Acute renal failure |
12 months
|
|
Conduction disturbances
Periodo de tiempo: 7 days
|
Incidence of conduction disturbances |
7 days
|
|
Conduction disturbances
Periodo de tiempo: 30 days
|
Incidence of conduction disturbances |
30 days
|
|
Conduction disturbances
Periodo de tiempo: 12 months
|
Incidence of conduction disturbances |
12 months
|
|
Arrhythmias
Periodo de tiempo: 7 days
|
Incidence of Arrhythmias |
7 days
|
|
Arrhythmias
Periodo de tiempo: 30 days
|
Incidence of Arrhythmias |
30 days
|
|
Arrhythmias
Periodo de tiempo: 12 months
|
Incidence of Arrhythmias |
12 months
|
|
Implantation of a new permanent pacemaker
Periodo de tiempo: 7 days
|
Incidence of Implantation of a new permanent pacemaker |
7 days
|
|
Implantation of a new permanent pacemaker
Periodo de tiempo: 30 days
|
Incidence of Implantation of a new permanent pacemaker |
30 days
|
|
Implantation of a new permanent pacemaker
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 12 months
|
Proportion of patients with modification of NYHA before the procedure and its modification after the procedure |
12 months
|
|
Echocardiographic Valve Dysfunction Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.
- Senguttuvan NB, Jose J, Sonawane A, Bansal S, Gupta R, Chandra P. Clinical evaluation of the Hydra self-expanding THV: 30-day results from the GENESIS-II study. AsiaIntervention. 2025 Oct 10;11(3):155-163. doi: 10.4244/AIJ-D-24-00075. eCollection 2025 Oct.
- Aidietis A, Srimahachota S, Dabrowski M, Bilkis V, Buddhari W, Cheung GSH, Nair RK, Mussayev AA, Mattummal S, Chandra P, Mahajan AU, Chmielak Z, Govindan SC, Jose J, Hiremath MS, Chandra S, Shetty R, Mohanan S, John JF, Mehrotra S, Sondergaard L. 30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):93-104. doi: 10.1016/j.jcin.2021.09.004.
- Marin-Cuartas M, Kawczynski MJ, de Waha S, Kiefer P, Falk V, Siepe M, Bowdish ME, Akowuah E, Verbrugghe P, Oosterlinck W, Klautz RJM, Lorusso R, Bidar E, Rahouma MM, Redfors B, Biondi-Zoccai G, Bhatt DL, Gaudino M, Borger MA, Heuts S. Updated 5-year outcomes of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low- to intermediate-surgical risk. Heart. 2026 Feb 11:heartjnl-2025-327092. doi: 10.1136/heartjnl-2025-327092. Online ahead of print.
- Sonawane A, Chandra P, Jose J, Bansal S, Gupta R, Sudhir K, Senguttuvan NB. Safety and performance of the Hydra self-expanding THV: 6 months outcomes from the GENESIS-II study. Indian Heart J. 2026 Jul-Aug;78(4):201-205. doi: 10.1016/j.ihj.2026.03.004. Epub 2026 Mar 10.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- rEpic22-HYSPANIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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