Home › Trials › NCT04861805

Evaluation of a new self-expanding aortic valve for severe aortic stenosis

A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System

Not applicable Interventional P+F Products + Features GmbH · NCT04861805

This study is testing a new self-expanding heart valve to see if it is safe and effective for people with severe aortic stenosis.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment267 (estimated)
Ages65 Years and up
SexAll
SponsorP+F Products + Features GmbH Industry-sponsored
Locations31 sites (Bahía Blanca and 30 other locations)
Trial IDNCT04861805 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Vienna Aortic Valve SE System in patients suffering from symptomatic severe aortic stenosis. It is a prospective, single-arm, multicenter study involving up to 267 patients who will be monitored for up to 5 years. Participants will undergo a series of follow-up visits to evaluate the performance of the valve after implantation, with primary safety and effectiveness endpoints assessed at 30 days post-procedure. The study builds on previous feasibility findings and aims to provide comprehensive data on long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 65 and older with symptomatic severe aortic stenosis who are at intermediate or high risk for surgical valve replacement.

Not a fit: Patients who are not symptomatic or those with low surgical risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with severe aortic stenosis, potentially improving their quality of life and survival rates.

How similar studies have performed: Other studies have shown success with similar transcatheter heart valve approaches, indicating a promising avenue for treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. Male or Female
2. Age ≥ 65 years at time of consent
3. Women of non-childbearing potential
4. Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:

   1. Aortic valve area (AVA) \< 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
   2. Jet velocity \> 4.0 m/s or mean gradient \> 40 mmHg
5. Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:

   1. Dyspnea that qualifies at NYHA class II or greater
   2. Angina pectoris
   3. Cardiac syncope
6. Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:

   1. EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines
   2. Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.
7. The local Heart Team deems the patient to be eligible for transfemoral TAVI.
8. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab.
9. Adequate iliofemoral access with either:

   1. At least one side with minimum vessel diameter ≥ 6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR
   2. At least one side with minimum vessel diameter ≥ 5.5 and no significant calcification or severe tortuosity for safe placement of the introducer sheath, as analyzed by a core lab.
10. Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
11. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Cardiovascular System:

1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
2. Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
3. Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
4. Patient has a hypertrophic obstructive cardiomyopathy.
5. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).
6. Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
9. Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block \>I) at screening and at time of IMD implantation.
10. Patient has severe peripheral vascular disease:

    1. including aortic aneurysm defined as maximal luminal diameter \> 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick \[\> 5 mm\], protruding or ulcerated atheroma in the aortic arch) or
    2. symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.
11. Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:

    1. severe calcification,
    2. severe tortuosity (\> two 90-degree bends),
    3. diameter \< 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity
    4. diameter \< 5.5, in patients with no calcification and no significant tortuosity, OR
    5. subject has had an aorto-femoral bypass
12. Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.
13. Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation.
14. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).
15. Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.
16. Patient has a need for emergency surgery for any reason at time of screening or IMD implantation.

    General:
17. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)
18. Patient with renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level \> 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening
19. Patient with significant pulmonary disease (FEV1 \< 30%) or currently on home oxygen
20. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)
21. Patients with evidence of an active systemic infection or sepsis.
22. Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.
23. Patient has a haemoglobin \< 9 g/dL, platelet count \< 50,000 cells/mm3 or \> 700.000 cells/mm3, or white blood cell count \< 1.000 cells/mm3, history of bleeding diathesis or coagulopathy
24. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.
25. Patient refuses blood transfusions.
26. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).
27. Patient is pregnant or breast feeding.
28. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
29. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams.
30. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).

Where this trial is running

Bahía Blanca and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Symptomatic Aortic Stenosisheart diseaseaortic valveSSASsymptomatic severe aortic stenosisheart valve
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.