Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis · Valvular Heart Disease · Aortic Valve Stenosis
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 100 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Hydra Transcatheter Heart Valve (THV)
Not reported in this registry record.
Device: Hydra THV
Hydra THV DEVICE
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
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 measures
All cause mortality
Time frame: 7 days
Incidence of all cause mortality
All cause mortality
Time frame: 30 days
Incidence of all cause mortality
All cause mortality
Time frame: 12 months
Incidence of all cause mortality
Cardiovascular mortality
Time frame: 7 days
Incidence of cardiovascular mortality
Cardiovascular mortality
Time frame: 30 days
Incidence of cardiovascular mortality
Cardiovascular mortality
Time frame: 12 months
Incidence of cardiovascular mortality
Stroke
Time frame: 7 days
Incidence of Stroke
Stroke
Time frame: 30 days
Incidence of Stroke
Stroke
Time frame: 12 months
Incidence of Stroke
Stroke with disabling
Time frame: 7 days
Incidence of Stroke with disabling
Stroke with disabling
Time frame: 30 days
Incidence of Stroke with disabling
Stroke with disabling
Time frame: 12 months
Incidence of Stroke with disabling
Stroke with non disabling
Time frame: 7 days
Incidence of Stroke with non disabling
Stroke with non disabling
Time frame: 30 days
Incidence of Stroke with non disabling
Stroke with non disabling
Time frame: 12 months
Incidence of Stroke with non disabling
Acute myocardial infarction
Time frame: 7 days
Incidence of acute myocardial infarction
Acute myocardial infarction
Time frame: 30 days
Incidence of acute myocardial infarction
Acute myocardial infarction
Time frame: 12 months
Incidence of acute myocardial infarction
Coronary occlusion
Time frame: 7days
Incidence of coronary occlusion
Coronary occlusion
Time frame: 30 days
Incidence of coronary occlusion
Coronary occlusion
Time frame: 12 months
Incidence of coronary occlusion
Haemorrhagic complications
Time frame: 7 days
Incidence of haemorrhagic complications
Haemorrhagic complications
Time frame: 30 days
Incidence of haemorrhagic complications
Haemorrhagic complications
Time frame: 12 months
Incidence of haemorrhagic complications
Vascular complications
Time frame: 7 days
Incidence of vascular complications
Vascular complications
Time frame: 30 days
Incidence of vascular complications
Vascular complications
Time frame: 12 Months
Incidence of vascular complications
Acute renal failure
Time frame: 7 days
Incidence of Acute renal failure
Acute renal failure
Time frame: 30 days
Incidence of Acute renal failure
Acute renal failure
Time frame: 12 months
Incidence of Acute renal failure
Conduction disturbances
Time frame: 7 days
Incidence of conduction disturbances
Conduction disturbances
Time frame: 30 days
Incidence of conduction disturbances
Conduction disturbances
Time frame: 12 months
Incidence of conduction disturbances
Arrhythmias
Time frame: 7 days
Incidence of Arrhythmias
Arrhythmias
Time frame: 30 days
Incidence of Arrhythmias
Arrhythmias
Time frame: 12 months
Incidence of Arrhythmias
Implantation of a new permanent pacemaker
Time frame: 7 days
Incidence of Implantation of a new permanent pacemaker
Implantation of a new permanent pacemaker
Time frame: 30 days
Incidence of Implantation of a new permanent pacemaker
Implantation of a new permanent pacemaker
Time frame: 12 months
Incidence of Implantation of a new permanent pacemaker
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.
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
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
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
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
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
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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (8)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
8 locations
Hospital Clínico San CarlosAravaca, SpainRecruiting
Hospital de la Santa Creu i Sant PauBarcelona, SpainRecruiting
Hospital Universitario La PazFuencarral-El Pardo, SpainRecruiting
Hospital Universitari de BellvitgeL'Hospitalet de Llobregat, SpainRecruiting
Hospital Universitari de SalamancaSalamanca, SpainRecruiting
Hospital Clínico Universitario de SantiagoSantiago de Compostela, SpainRecruiting
Hospital Universitario Virgen del RocioSeville, SpainRecruiting
Hospital General Universitario de ToledoToledo, SpainRecruiting
Study team and timeline
- Lead sponsor
- Fundación EPIC
- Study start
- Jul 7, 2026 Actual
- Primary completion
- Jan 1, 2029 Estimated
- Study completion
- Feb 1, 2029 Estimated
- First posted
- May 5, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026