Recruiting NCT07566624

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

— Observational Severe Aortic Valve Stenosis Valvular Heart Disease Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Hydra THV.
Who it may be relevant to: Registry conditions: Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Spain
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

Assessment of the success rate of implantation [Time frame: 7 days]
Success of the procedure [Time frame: 7 days]

Secondary outcome measures (12)

All cause mortality [Time frame: 7 days]
All cause mortality [Time frame: 30 days]
All cause mortality [Time frame: 12 months]
Cardiovascular mortality [Time frame: 7 days]
Cardiovascular mortality [Time frame: 30 days]
Cardiovascular mortality [Time frame: 12 months]
Stroke [Time frame: 7 days]
Stroke [Time frame: 30 days]
Stroke [Time frame: 12 months]
Stroke with disabling [Time frame: 7 days]
Stroke with disabling [Time frame: 30 days]
Stroke with disabling [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-only

Study locations

Spain · 2 centers

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

Publications

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

Identifiers

NCT: NCT07566624 · rEpic22-HYSPANIA

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗