Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Hydra THV
  Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.

Первичные конечные точки

• Assessment of the success rate of implantation [Срок оценки: 7 days]
• Success of the procedure [Срок оценки: 7 days]

Вторичные конечные точки (12)

• All cause mortality [Срок оценки: 7 days]
• All cause mortality [Срок оценки: 30 days]
• All cause mortality [Срок оценки: 12 months]
• Cardiovascular mortality [Срок оценки: 7 days]
• Cardiovascular mortality [Срок оценки: 30 days]
• Cardiovascular mortality [Срок оценки: 12 months]
• Stroke [Срок оценки: 7 days]
• Stroke [Срок оценки: 30 days]
• Stroke [Срок оценки: 12 months]
• Stroke with disabling [Срок оценки: 7 days]
• Stroke with disabling [Срок оценки: 30 days]
• Stroke with disabling [Срок оценки: 12 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Испания · 2 центра

• Hospital Universitario La Paz — Fuencarral-El Pardo
• Hospital Clínico Universitario de Santiago — Santiago de Compostela

Публикации

• 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. PMID 41049310
• 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. do PMID 34991828
• 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 Mar 10:S0019-4832(26)00035-0. doi: 10.1016/j.ihj.2026.03.004. Online ahead of print. PMID 41819447
• 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. Hear PMID 41672766
• 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 PMID 40878295

Идентификаторы

NCT: NCT07566624 · rEpic22-HYSPANIA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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