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NCT Number: NCT07566624

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

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.

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Key information

Conditions

Severe Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Valvular Heart Disease Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario La Paz

Fuencarral-El Pardo, 28046, Spain

Location status: Recruiting

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydra THV

Device

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

Primary outcomes

  1. Assessment of the success rate of implantation

    Time frame: 7 days

    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

  2. Success of the procedure

    Time frame: 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.

Secondary outcomes

  1. All cause mortality

    Time frame: 7 days

    Incidence of all cause mortality

  2. All cause mortality

    Time frame: 30 days

    Incidence of all cause mortality

  3. All cause mortality

    Time frame: 12 months

    Incidence of all cause mortality

  4. Cardiovascular mortality

    Time frame: 7 days

    Incidence of cardiovascular mortality

  5. Cardiovascular mortality

    Time frame: 30 days

    Incidence of cardiovascular mortality

  6. Cardiovascular mortality

    Time frame: 12 months

    Incidence of cardiovascular mortality

  7. Stroke

    Time frame: 7 days

    Incidence of Stroke

  8. Stroke

    Time frame: 30 days

    Incidence of Stroke

  9. Stroke

    Time frame: 12 months

    Incidence of Stroke

  10. Stroke with disabling

    Time frame: 7 days

    Incidence of Stroke with disabling

  11. Stroke with disabling

    Time frame: 30 days

    Incidence of Stroke with disabling

  12. Stroke with disabling

    Time frame: 12 months

    Incidence of Stroke with disabling

  13. Stroke with non disabling

    Time frame: 7 days

    Incidence of Stroke with non disabling

  14. Stroke with non disabling

    Time frame: 30 days

    Incidence of Stroke with non disabling

  15. Stroke with non disabling

    Time frame: 12 months

    Incidence of Stroke with non disabling

  16. Acute myocardial infarction

    Time frame: 7 days

    Incidence of acute myocardial infarction

  17. Acute myocardial infarction

    Time frame: 30 days

    Incidence of acute myocardial infarction

  18. Acute myocardial infarction

    Time frame: 12 months

    Incidence of acute myocardial infarction

  19. Coronary occlusion

    Time frame: 7days

    Incidence of coronary occlusion

  20. Coronary occlusion

    Time frame: 30 days

    Incidence of coronary occlusion

  21. Coronary occlusion

    Time frame: 12 months

    Incidence of coronary occlusion

  22. Haemorrhagic complications

    Time frame: 7 days

    Incidence of haemorrhagic complications

  23. Haemorrhagic complications

    Time frame: 30 days

    Incidence of haemorrhagic complications

  24. Haemorrhagic complications

    Time frame: 12 months

    Incidence of haemorrhagic complications

  25. Vascular complications

    Time frame: 7 days

    Incidence of vascular complications

  26. Vascular complications

    Time frame: 30 days

    Incidence of vascular complications

  27. Vascular complications

    Time frame: 12 Months

    Incidence of vascular complications

  28. Acute renal failure

    Time frame: 7 days

    Incidence of Acute renal failure

  29. Acute renal failure

    Time frame: 30 days

    Incidence of Acute renal failure

  30. Acute renal failure

    Time frame: 12 months

    Incidence of Acute renal failure

  31. Conduction disturbances

    Time frame: 7 days

    Incidence of conduction disturbances

  32. Conduction disturbances

    Time frame: 30 days

    Incidence of conduction disturbances

  33. Conduction disturbances

    Time frame: 12 months

    Incidence of conduction disturbances

  34. Arrhythmias

    Time frame: 7 days

    Incidence of Arrhythmias

  35. Arrhythmias

    Time frame: 30 days

    Incidence of Arrhythmias

  36. Arrhythmias

    Time frame: 12 months

    Incidence of Arrhythmias

  37. Implantation of a new permanent pacemaker

    Time frame: 7 days

    Incidence of Implantation of a new permanent pacemaker

  38. Implantation of a new permanent pacemaker

    Time frame: 30 days

    Incidence of Implantation of a new permanent pacemaker

  39. Implantation of a new permanent pacemaker

    Time frame: 12 months

    Incidence of Implantation of a new permanent pacemaker

  40. Combined safety event at 30 days defined by Valve Academic Research Consortium 3 (VARC-3) criteria

    Time frame: 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.

  41. New York Heart Association (NYHA)

    Time frame: 7 days

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

  42. New York Heart Association (NYHA)

    Time frame: 30 days

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

  43. New York Heart Association (NYHA)

    Time frame: 12 months

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

  44. Echocardiographic Valve Dysfunction Assessment

    Time frame: 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

  45. Echocardiographic Valve Dysfunction Assessment

    Time frame: 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

  46. Echocardiographic Valve Dysfunction Assessment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

FUNDACION EPIC

CONTACT

[email protected]

0034987876135

RAUL MORENO GOMEZ, MD, PhD

CONTACT

[email protected]

0034917277000

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Acronym: HYSPANIA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 5, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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