Severe Aortic Valve StenosisHYSPANIANCT07566624
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
An observational study of Severe Aortic Valve Stenosis and Valvular Heart Disease, run by Fundación EPIC at 5 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis
- What is being tested?
- Hydra THV
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesSpain
- Study dates
- 7 Jul 2026to 1 Feb 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
- Recruiting
Hospital Universitario La Paz
Fuencarral-El Pardo, 28046
- Recruiting
Hospital Universitari de Salamanca
Salamanca, 37007
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15706
- Recruiting
Hospital General Universitario de Toledo
Toledo, 45007
About this study
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.
Read the detailed description
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.
- Being tested
- Hydra THV
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydra THVDevice
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
| Study group | Role | What they receive |
|---|---|---|
| Hydra Transcatheter Heart Valve (THV) | Not described Receives: Device: Hydra THV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the success rate of implantation
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
Measured: 7 days
Success of the procedure
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.
Measured: 7 days
Secondary outcomes (46)
All cause mortality
Incidence of all cause mortality
Measured: 7 days
All cause mortality
Incidence of all cause mortality
Measured: 30 days
All cause mortality
Incidence of all cause mortality
Measured: 12 months
Cardiovascular mortality
Incidence of cardiovascular mortality
Measured: 7 days
Cardiovascular mortality
Incidence of cardiovascular mortality
Measured: 30 days
Cardiovascular mortality
Incidence of cardiovascular mortality
Measured: 12 months
Stroke
Incidence of Stroke
Measured: 7 days
Stroke
Incidence of Stroke
Measured: 30 days
Stroke
Incidence of Stroke
Measured: 12 months
Stroke with disabling
Incidence of Stroke with disabling
Measured: 7 days
Stroke with disabling
Incidence of Stroke with disabling
Measured: 30 days
Stroke with disabling
Incidence of Stroke with disabling
Measured: 12 months
Stroke with non disabling
Incidence of Stroke with non disabling
Measured: 7 days
Stroke with non disabling
Incidence of Stroke with non disabling
Measured: 30 days
Stroke with non disabling
Incidence of Stroke with non disabling
Measured: 12 months
Acute myocardial infarction
Incidence of acute myocardial infarction
Measured: 7 days
Acute myocardial infarction
Incidence of acute myocardial infarction
Measured: 30 days
Acute myocardial infarction
Incidence of acute myocardial infarction
Measured: 12 months
Coronary occlusion
Incidence of coronary occlusion
Measured: 7days
Coronary occlusion
Incidence of coronary occlusion
Measured: 30 days
Coronary occlusion
Incidence of coronary occlusion
Measured: 12 months
Haemorrhagic complications
Incidence of haemorrhagic complications
Measured: 7 days
Haemorrhagic complications
Incidence of haemorrhagic complications
Measured: 30 days
Haemorrhagic complications
Incidence of haemorrhagic complications
Measured: 12 months
Vascular complications
Incidence of vascular complications
Measured: 7 days
Vascular complications
Incidence of vascular complications
Measured: 30 days
Vascular complications
Incidence of vascular complications
Measured: 12 Months
Acute renal failure
Incidence of Acute renal failure
Measured: 7 days
Acute renal failure
Incidence of Acute renal failure
Measured: 30 days
Acute renal failure
Incidence of Acute renal failure
Measured: 12 months
Conduction disturbances
Incidence of conduction disturbances
Measured: 7 days
Conduction disturbances
Incidence of conduction disturbances
Measured: 30 days
Conduction disturbances
Incidence of conduction disturbances
Measured: 12 months
Arrhythmias
Incidence of Arrhythmias
Measured: 7 days
Arrhythmias
Incidence of Arrhythmias
Measured: 30 days
Arrhythmias
Incidence of Arrhythmias
Measured: 12 months
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Measured: 7 days
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Measured: 30 days
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Measured: 12 months
Combined safety event at 30 days defined by Valve Academic Research Consortium 3 (VARC-3) criteria
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.
Measured: 30 days
New York Heart Association (NYHA)
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
Measured: 7 days
New York Heart Association (NYHA)
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
Measured: 30 days
New York Heart Association (NYHA)
Proportion of patients with modification of NYHA before the procedure and its modification after the procedure
Measured: 12 months
Echocardiographic Valve Dysfunction Assessment
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
Measured: 7 days
Echocardiographic Valve Dysfunction Assessment
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
Measured: 30 days
Echocardiographic Valve Dysfunction Assessment
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start7 Jul 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566624
- Sponsor's protocol ID
- rEpic22-HYSPANIA
- Acronym
- HYSPANIA
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 41049310Aidietis 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.
PubMed 34991828Sonawane 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.
PubMed 41819447Marin-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.
PubMed 41672766Praz 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.
PubMed 40878295