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RecruitingNCT07566624HYSPANIAUpdated Sep 30, 2026

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

An observational study in Severe Aortic Valve Stenosis, Valvular Heart Disease and Aortic Valve Stenosis, sponsored by Fundación EPIC. Recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Fundación EPIC · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Severe Aortic Valve Stenosis
  • Valvular Heart Disease
  • Aortic Valve Stenosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Hydra Transcatheter Heart Valve (THV)

    Device: Hydra THV

Interventions

  • DeviceHydra THV

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 days

  2. 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.

    Time frame: 7 days

Secondary outcomes

  1. All cause mortality

    Incidence of all cause mortality

    Time frame: 7 days

  2. All cause mortality

    Incidence of all cause mortality

    Time frame: 30 days

  3. All cause mortality

    Incidence of all cause mortality

    Time frame: 12 months

  4. Cardiovascular mortality

    Incidence of cardiovascular mortality

    Time frame: 7 days

  5. Cardiovascular mortality

    Incidence of cardiovascular mortality

    Time frame: 30 days

  6. Cardiovascular mortality

    Incidence of cardiovascular mortality

    Time frame: 12 months

  7. Stroke

    Incidence of Stroke

    Time frame: 7 days

  8. Stroke

    Incidence of Stroke

    Time frame: 30 days

  9. Stroke

    Incidence of Stroke

    Time frame: 12 months

  10. Stroke with disabling

    Incidence of Stroke with disabling

    Time frame: 7 days

  11. Stroke with disabling

    Incidence of Stroke with disabling

    Time frame: 30 days

  12. Stroke with disabling

    Incidence of Stroke with disabling

    Time frame: 12 months

  13. Stroke with non disabling

    Incidence of Stroke with non disabling

    Time frame: 7 days

  14. Stroke with non disabling

    Incidence of Stroke with non disabling

    Time frame: 30 days

  15. Stroke with non disabling

    Incidence of Stroke with non disabling

    Time frame: 12 months

  16. Acute myocardial infarction

    Incidence of acute myocardial infarction

    Time frame: 7 days

  17. Acute myocardial infarction

    Incidence of acute myocardial infarction

    Time frame: 30 days

  18. Acute myocardial infarction

    Incidence of acute myocardial infarction

    Time frame: 12 months

  19. Coronary occlusion

    Incidence of coronary occlusion

    Time frame: 7days

  20. Coronary occlusion

    Incidence of coronary occlusion

    Time frame: 30 days

  21. Coronary occlusion

    Incidence of coronary occlusion

    Time frame: 12 months

  22. Haemorrhagic complications

    Incidence of haemorrhagic complications

    Time frame: 7 days

  23. Haemorrhagic complications

    Incidence of haemorrhagic complications

    Time frame: 30 days

  24. Haemorrhagic complications

    Incidence of haemorrhagic complications

    Time frame: 12 months

  25. Vascular complications

    Incidence of vascular complications

    Time frame: 7 days

  26. Vascular complications

    Incidence of vascular complications

    Time frame: 30 days

  27. Vascular complications

    Incidence of vascular complications

    Time frame: 12 Months

  28. Acute renal failure

    Incidence of Acute renal failure

    Time frame: 7 days

  29. Acute renal failure

    Incidence of Acute renal failure

    Time frame: 30 days

  30. Acute renal failure

    Incidence of Acute renal failure

    Time frame: 12 months

  31. Conduction disturbances

    Incidence of conduction disturbances

    Time frame: 7 days

  32. Conduction disturbances

    Incidence of conduction disturbances

    Time frame: 30 days

  33. Conduction disturbances

    Incidence of conduction disturbances

    Time frame: 12 months

  34. Arrhythmias

    Incidence of Arrhythmias

    Time frame: 7 days

  35. Arrhythmias

    Incidence of Arrhythmias

    Time frame: 30 days

  36. Arrhythmias

    Incidence of Arrhythmias

    Time frame: 12 months

  37. Implantation of a new permanent pacemaker

    Incidence of Implantation of a new permanent pacemaker

    Time frame: 7 days

  38. Implantation of a new permanent pacemaker

    Incidence of Implantation of a new permanent pacemaker

    Time frame: 30 days

  39. Implantation of a new permanent pacemaker

    Incidence of Implantation of a new permanent pacemaker

    Time frame: 12 months

  40. 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.

    Time frame: 30 days

  41. New York Heart Association (NYHA)

    Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure

    Time frame: 7 days

  42. New York Heart Association (NYHA)

    Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure

    Time frame: 30 days

  43. New York Heart Association (NYHA)

    Proportion of patients with modification of NYHA before the procedure and its modification after the procedure

    Time frame: 12 months

  44. 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

    Time frame: 7 days

  45. 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

    Time frame: 30 days

  46. 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

    Time frame: 12 months

06

Study locations

3 of 3 sites recruiting
  • Hospital Universitario La Paz
    Fuencarral-El Pardo, 28046, Spain
    Recruiting
  • Hospital Clínico Universitario de Santiago
    Santiago de Compostela, 15706, Spain
    Recruiting
  • Hospital General Universitario de Toledo
    Toledo, 45007, Spain
    Recruiting
07

References and documents

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 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. doi: 10.1016/j.jcin.2021.09.004. PubMed 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 Jul-Aug;78(4):201-205. doi: 10.1016/j.ihj.2026.03.004. Epub 2026 Mar 10. PubMed 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. Heart. 2026 Feb 11:heartjnl-2025-327092. doi: 10.1136/heartjnl-2025-327092. Online ahead of print. PubMed 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 Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available. PubMed 40878295 ↗
08

Registry details

Key details

Study ID
NCT07566624
Lead sponsor
Fundación EPIC
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Jul 7, 2026
Primary completion
Jan 1, 2029 (estimated)
Completion
Feb 1, 2029 (estimated)
Last update
Sep 30, 2026

Study contacts

RAUL MORENO GOMEZ, MD, PhD
Contact
raulmorenog@hotmail.com
0034917277000
FUNDACION EPIC
Contact
iepic@fundacionepic.org
0034987876135

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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