Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Not Applicable

Recruiting

• Conditions: Symptomatic Aortic Stenosis

• Registration Number: NCT04861805
• Lead Sponsor: P+F Products + Features GmbH

Brief Summary

This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.

Detailed Description

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The clinical trial is completed after all 267 patients, that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Study Start: 2023-07-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-10
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
All Cause Mortality (30 days)	up to 30 days	All-cause mortality at 30 days from the index procedure.

Secondary Outcome Measures

Name	Time	Method
Life-threatening bleeding	Up to 1 year	Life-threatening bleeding (at 30 days, 3 months, 6 months and 1 year post-implantation).
Rehospitalization	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)
New York Heart Association (NYHA) classification	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)
All-cause, cardiovascular and non-cardiovascular mortality	up to 5 years	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.
Periprocedural death	72 hours	Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death ≤72 h post-procedure)
Cerebrovascular event	Up to 5 years	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 \>24 h. By definition, a TIA does not produce a lasting disability.
Clinical Efficacy	1 year	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 \<45 or decline from baseline of \>10 point (i.e. Unfavourable Outcome)
Valve-related clinical efficacy	Up to 5 years	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)
Incidence of TAVI-related complications	periprocedural and during index hospitalization	Incidence of TAVI-related complications: 1. Valve-related complication requiring repeat procedure; 2. Vascular complications resulting in interventions; 3. Ventricular septal perforation ≤7 days after IMD implantation; 4. Acute kidney injury-Stage 2 or 3 ≤7 days post IMD implantation; 5. Coronary artery obstruction requiring intervention; 6. Atrio-ventricular block requiring pacemaker implantation; 7. Mitral valve apparatus damage or dysfunction; 8. Evidence of a new pericardial effusion/ tamponade related to the TAVI procedure; 9. Prosthetic valve endocarditis; 10. Prosthetic valve thrombosis; 11. Prosthetic valve mispositioning; 12. Prosthetic valve embolization; 13. Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or DVI peak velocity \>0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Conduction disturbances requiring permanent pacemaker implantation	Up to 5 years	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)
Change in exercise capacity measured as the 6-minute walk distance (6-MWD)	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)
Device Success	72 hours	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
Technical success	up to 30 days	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 \< 20 mmHg
Change in quality of life as assessed by the Kansas City Cardiomyopathy	1 year	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

Trial Locations

Locations (31)

Hospital Privado Sur (FUMEBA); 🇦🇷 Bahia Blanca, Argentina

Fundación Favaloro; 🇦🇷 Buenos Aires, Argentina

Hospital Italiano De Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Instituto Nacional de Cardiologia; 🇧🇷 Rio de Janeiro, Brazil

Instituto Estadual De Cardiologia Aloysio De Castro; 🇧🇷 Rio de Janeiro, Brazil

Instituto Dante Pazzanese De Cardiologia; 🇧🇷 São Paulo, Brazil

Escola Paulista de Medicina da UNIFESP; 🇧🇷 São Paulo, Brazil

Instituto Do Coração (InCor) De São Paulo; 🇧🇷 São Paulo, Brazil

Hospital Del Torax De Santiago; 🇨🇱 Santiago, Chile

Hospital Clínico San Borja Arriarán; 🇨🇱 Santiago, Chile

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