An observational study in Severe Aortic Valve Stenosis, Valvular Heart Disease and Aortic Valve Stenosis, sponsored by Fundación EPIC. Recruiting at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Fundación EPIC · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 83 studies in Aortic Valve Stenosis with a site in Spain — 25 open to participants now, 32 under way, 1 of them phase 3. Aortic Valve Stenosis · Spain.
Among the 83 studies in Aortic Valve Stenosis with a site in Spain, this one is the 41st largest by planned enrollment of the 46 observational ones that give a count, is one of 4 that started in 2026, is one of 46 observational ones, reaches primary completion later than 28 of the 31 other live ones, and was the 81st registered.
1,026 studies on the registry are indexed under Aortic Valve Stenosis; 294 are open to participants now.
Browse Aortic Valve Stenosis studies →25 of the 83 studies in Aortic Valve Stenosis with a site in Spain are open now. Recruiting first, the newest first:
Hospital Universitari Vall d'Hebron Research Institute · Sites in Spain
Ages 18+
Biosensors Europe SA · Sites in Spain
Ages 18+
Ceric Sàrl · Sites in Spain, Austria, Estonia and 11 more countries
Ages 65–75
Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Sites in Spain, Ireland, Italy and 2 more countries
Ages 18+
Hospital Clinic of Barcelona · Sites in Spain
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 3 · Phase 4 7
First in 2006; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is below the median of 200 across 436 observational studies indexed under Aortic Valve Stenosis.
Median enrollment 209 across the 37 interventional studies, 373 across the 46 observational. Of the 42 that completed or were terminated, 9 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
37 of 83 have an industry lead sponsor. The 10 most frequent:
Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.
Fundación EPIC has 4 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Aortic Valve Stenosis with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05758909Fundación EPICEvaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation | 2026-12-01 |
| NCT06833762Hospital Clinic of BarcelonaClinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI | 2027-06 |
| NCT05283356Fundacin Biomedica Galicia SurSingle Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation | 2027-06-30 |
| NCT06008080Abbott Medical DevicesPost-Market Clinical Follow Up Study With Navitor Valve | 2027-07 |
| NCT06049654Fundación EPICComparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication | 2027-11-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 83 studies in Aortic Valve Stenosis with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants who meet ALL of the following conditions will be included:
Exclusion Criteria:
Patients who do NOT meet ANY of the following conditions will be included:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Hydra THV
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
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
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
All cause mortality
Incidence of all cause mortality
Time frame: 7 days
All cause mortality
Incidence of all cause mortality
Time frame: 30 days
All cause mortality
Incidence of all cause mortality
Time frame: 12 months
Cardiovascular mortality
Incidence of cardiovascular mortality
Time frame: 7 days
Cardiovascular mortality
Incidence of cardiovascular mortality
Time frame: 30 days
Cardiovascular mortality
Incidence of cardiovascular mortality
Time frame: 12 months
Stroke
Incidence of Stroke
Time frame: 7 days
Stroke
Incidence of Stroke
Time frame: 30 days
Stroke
Incidence of Stroke
Time frame: 12 months
Stroke with disabling
Incidence of Stroke with disabling
Time frame: 7 days
Stroke with disabling
Incidence of Stroke with disabling
Time frame: 30 days
Stroke with disabling
Incidence of Stroke with disabling
Time frame: 12 months
Stroke with non disabling
Incidence of Stroke with non disabling
Time frame: 7 days
Stroke with non disabling
Incidence of Stroke with non disabling
Time frame: 30 days
Stroke with non disabling
Incidence of Stroke with non disabling
Time frame: 12 months
Acute myocardial infarction
Incidence of acute myocardial infarction
Time frame: 7 days
Acute myocardial infarction
Incidence of acute myocardial infarction
Time frame: 30 days
Acute myocardial infarction
Incidence of acute myocardial infarction
Time frame: 12 months
Coronary occlusion
Incidence of coronary occlusion
Time frame: 7days
Coronary occlusion
Incidence of coronary occlusion
Time frame: 30 days
Coronary occlusion
Incidence of coronary occlusion
Time frame: 12 months
Haemorrhagic complications
Incidence of haemorrhagic complications
Time frame: 7 days
Haemorrhagic complications
Incidence of haemorrhagic complications
Time frame: 30 days
Haemorrhagic complications
Incidence of haemorrhagic complications
Time frame: 12 months
Vascular complications
Incidence of vascular complications
Time frame: 7 days
Vascular complications
Incidence of vascular complications
Time frame: 30 days
Vascular complications
Incidence of vascular complications
Time frame: 12 Months
Acute renal failure
Incidence of Acute renal failure
Time frame: 7 days
Acute renal failure
Incidence of Acute renal failure
Time frame: 30 days
Acute renal failure
Incidence of Acute renal failure
Time frame: 12 months
Conduction disturbances
Incidence of conduction disturbances
Time frame: 7 days
Conduction disturbances
Incidence of conduction disturbances
Time frame: 30 days
Conduction disturbances
Incidence of conduction disturbances
Time frame: 12 months
Arrhythmias
Incidence of Arrhythmias
Time frame: 7 days
Arrhythmias
Incidence of Arrhythmias
Time frame: 30 days
Arrhythmias
Incidence of Arrhythmias
Time frame: 12 months
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Time frame: 7 days
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Time frame: 30 days
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Time frame: 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.
Time frame: 30 days
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
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
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
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
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
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
Started Jul 2026 (actual). Primary completion is estimated for Jan 2029, 29 months after the start.
Of 206 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 29 months is below that.
Counting every sponsor, half of 243 studies reached it within 44 months; a quarter within 23 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundación EPIC