Vienna Aortic Valve SE – Self-expandable Transcatheter Valve
System (Transcatheter bovine tissue valve)
The Vienna Aortic Valve is composed of nitinol self-expanding stent system, which supports a bovine pericardium valve with three leaflets designed to optimize hemodynamic flow by being positioned supra-annularly. Additionally, the valve includes a polyester fabric skirt fixed on the outside of the frame (outer wrap) by a polytetrafluoretlylene suture to cover the inflow portion of the valve, reducing the risk of paravalvular leak. In addition, the valve has a straight sealing zone, specially designed to enhance the valve’s contact with the Left Ventricular Outflow Tract (LVOT) during implantation of the valve, thereby reducing the possibility of paravalvular leakage. For over three decades, bovine pericardium has been utilized to construct bioprosthetic valve leaflets, with the materials mechanical properties being a critical factor in the function and performance of the Bioprosthesis. Thus, it is crucial to characterize the properties of the pericardial material used for constructing the leaflets. The glutaraldehyde crosslinked bovine pericardium is sterile and appears as a light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen. The material has a shelf life of six months from the time of harvesting when stored between 2°C to 25°C, and has been evaluated in-house. Bovine pericardium has multiple application, including use as a pericardial closure patch, repair of cardiac and vascular defects, septal defects, valve leaflets, vessels reconstruction, and suture line buttressing.
Inclusion Criteria
Age From
65.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Male or Female.
2.Age greater than or equal to 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: a. Aortic valve area (AVA) less than 1.0 cm2 or AVA index less than or equal to 0.6 cm2/m2 and b. Jet velocity greater than4.0 m/s or mean gradient greater than 40 mmHg
5.Symptomatic aortic stenosis (AS), defined as a history of at least one of the following: a. Dyspnoea that qualifies at NYHA class II or greater b. Angina pectoris c. Cardiac syncope
6.Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following: a. EuroSCORE II greater than or equal to 4 percentage along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines b. 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 greater than or equal to18 and less than or equal to 29 mm measured by computed tomography (CT) analyzed by a core lab.
9.Adequate iliofemoral access with either: a. At least one side with minimum vessel diameter greater than equal to6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR b. At least one side with minimum vessel diameter greater than or equal to 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
ExclusionCriteria
Details
Cardiovascular System
1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
2. Evidence of an acute myocardial infarction (MI) less than or equal to 30 days prior to screening or IMD implantation (defined as Q-wave MI or non Q-wave MI with total CK elevation greater than or equal to 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 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) less than 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 greater than I) at screening and at time of IMD implantation.
10. Patient has severe peripheral vascular disease: a. including aortic aneurysm defined as maximal luminal diameter greater than 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [greater than 5 mm], protruding or ulcerated atheroma in the aortic arch) or b. 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: a. severe calcification, b. severe tortuosity (greater than two 90-degree bends), c. diameter less than 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity d. diameter less than 5.5, in patients with no calcification and no significant tortuosity, OR e. 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 less than 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level greater than 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening.
19. Patient with significant pulmonary disease (FEV1 less than 30%) or currently on home oxygen. 20. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure greater than or equal to 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 less than 9 g/dL, platelet count less than 50,000 cells/mm3 or greater than 700.000 cells/mm3, or white blood cell count less than 1.000 cells/mm3, or 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).
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
All-cause mortality at 30 days from the index procedure.
All-cause mortality at 30 days from the index procedure.
Secondary Outcome
Outcome
TimePoints
All-cause, cardiovascular and non-cardiovascular mortality at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation.
up to 5 years
Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death less than or equal to 72 h post-procedure)
Conduction disturbances requiring permanent pacemaker implantation (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation)
up to 5 years
Re-hospitalization for valve-related complications or worsening congestive heart failure (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation)
up to 5 years
Device success defined as:
a. correct positioning of a single prosthetic investigational heart valve in the proper anatomical location AND ability to provide appropriate hemodynamic AND absence of peri-procedural mortality within 72 hours after implantation
72 hours
Technical success defined as
1. successful vascular access, delivery and deployment of the IMD and successful retrieval of the delivery system; and
2. correct positioning of a single prosthetic investigational heart valve in the proper anatomical location
3. in patients alive at 30 days with implanted Vienna valve:
1. Total aortic regurgitation of none/trace/mild/mild-moderate
2. Patient prosthesis mismatch (PPM) insignificant
3. Mean gradient less than 20 mmHg
up to 30 days
Clinical efficacy (at 1 year and thereafter)
1. Freedom from all-cause mortality
2. Freedom from all stroke
3. Freedom from hospitalization for procedure- or valve-related causes
4. Freedom from KCCQ Overall Summary Score less than 45 or decline from baseline of more than10 point (i.e. Unfavourable Outcome)
1 year
Valve-related clinical efficacy
1. Freedom from bioprosthetic Valve Failure (defined as: Valve-related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 haemodynamic valve deterioration)
2. Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
3. Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
up to 5 years
Change in heart failure symptoms from baseline as assessed by the New York Heart Association (NYHA) classification (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation)
up to 5 years
Scale from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
1 year
Change in exercise capacity from baseline measured as the 6-minute walk distance (6-MWD) (at 30 days, 3 months, 6 months and 1 year post-implantation)
1 year
Cerebrovascular event (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation):
1. Stroke, defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction
2. Transient ischemic attack (TIA), defined as a transient episode of focal neurological dysfunction caused by the brain, spinal cord, or retinal ischemia, without acute infarction. The difference between TIA and ischemic stroke is the presence of tissue damage on neuro-imaging studies or new sensory-motor deficit persisting more than 24 h. By definition, a TIA does not produce a lasting disability
up to 5 years
Target Sample Size
Total Sample Size="267" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
10/11/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
03/07/2023
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="5" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The purpose of
this trial is to determine the safety and effectiveness of the Vienna Aortic
Valve SE System, a new self-expanding transcatheter heart valve, in patients
with symptomatic severe aortic stenosis (SSAS). This is a prospective, single
arm, multicenter study in an expanding cohort of symptomatic patients with
severe aortic stenosis following the FIH feasibility study. The clinical
investigation comprises 11 visits (V1 to V11). After implantation of the IMD at
visit 2, safety and effectiveness assessment of the device will be performed at
30 days (V4), 3 months (V5), 6 months (V6), 1 year (V7) and every year
thereafter up to 5 years post-implantation (V8 to V11).
In summary, the
clinical investigation for the individual patient will end after 5 years with a
full clinical evaluation. The primary study endpoints for safety and
effectiveness will be reached at 30-day follow-up timepoint.
The clinical trial
is completed after all 267 patients, that are not prematurely withdrawn, have
completed their 5-year follow-up visit involving all specified assessments.