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.
Studieöversikt
Status
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
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: FUNDACION EPIC
- Telefonnummer: 0034987876135
- E-post: iepic@fundacionepic.org
Studera Kontakt Backup
- Namn: RAUL MORENO GOMEZ, MD, PhD
- Telefonnummer: 0034917277000
- E-post: raulmorenog@hotmail.com
Studieorter
-
-
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Aravaca, Spanien, 28040
- Rekrytering
- Hospital Clínico San Carlos
-
Barcelona, Spanien, 08041
- Rekrytering
- Hospital de la Santa Creu i Sant Pau
-
Fuencarral-El Pardo, Spanien, 28046
- Rekrytering
- Hospital Universitario La Paz
-
L'Hospitalet de Llobregat, Spanien, 08907
- Rekrytering
- Hospital Universitari de Bellvitge
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Salamanca, Spanien, 37007
- Rekrytering
- Hospital Universitari de Salamanca
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Santiago de Compostela, Spanien, 15706
- Rekrytering
- Hospital Clínico Universitario de Santiago
-
Seville, Spanien, 41013
- Rekrytering
- Hospital Universitario Virgen del Rocio
-
Toledo, Spanien, 45007
- Rekrytering
- Hospital General Universitario de Toledo
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Hydra Transcatheter Heart Valve (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:
|
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 |
|---|---|---|
|
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
|
|
Cardiovascular mortality
Tidsram: 12 months
|
Incidence of cardiovascular mortality |
12 months
|
|
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
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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