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Symptomatic Aortic StenosisVIVANCT04861805

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

A study testing Vienna Aortic Valve SE System in people with Symptomatic Aortic Stenosis, run by P+F Products + Features GmbH at 31 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Symptomatic Aortic Stenosis
What is being tested?
Vienna Aortic Valve SE System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
31 sitesin 8 countries
Study dates
3 Jul 2023to Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Male or Female
  • Age ≥ 65 years at time of consent
  • Women of non-childbearing potential
  • Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:
  • Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
  • Jet velocity > 4.0 m/s or mean gradient > 40 mmHg
Show all 20Show fewer
  • Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:
  • Dyspnea that qualifies at NYHA class II or greater
  • Angina pectoris
  • Cardiac syncope
  • Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:
  • EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines
  • Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.
  • The local Heart Team deems the patient to be eligible for transfemoral TAVI.
  • Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab.
  • Adequate iliofemoral access with either:
  • 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
  • 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.
  • Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
  • The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Who cannot join

  • Cardiovascular System:
  • Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
  • 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).
  • Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
  • Patient has a hypertrophic obstructive cardiomyopathy.
  • 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).
Show all 39Show fewer
  • Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
  • Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
  • Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
  • 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.
  • Patient has severe peripheral vascular disease:
  • 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
  • symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.
  • Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:
  • severe calcification,
  • severe tortuosity (> two 90-degree bends),
  • diameter < 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity
  • diameter < 5.5, in patients with no calcification and no significant tortuosity, OR
  • subject has had an aorto-femoral bypass
  • Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.
  • Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation.
  • Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).
  • Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.
  • Patient has a need for emergency surgery for any reason at time of screening or IMD implantation.
  • General:
  • Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)
  • 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
  • Patient with significant pulmonary disease (FEV1 < 30%) or currently on home oxygen
  • Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)
  • Patients with evidence of an active systemic infection or sepsis.
  • 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.
  • 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
  • Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.
  • Patient refuses blood transfusions.
  • 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).
  • Patient is pregnant or breast feeding.
  • 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).
  • 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.
  • Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).

Trial locations and contacts

31 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Katharina Kiss, Dr contact

+4369913289414

kkiss@productsandfeatures.com

Monica Tocchi, MD, PhD contact

9176841700

m.tocchi@meditrial.net

31 sites in 8 countries

Spain8 sites, 8 recruiting

  • Hospital Clinic De Barcelona

    Barcelona, Barcelona, 08036

    Ander Regueiro, MD, +34 932 27 54 00, aregueir@clinic.cat

    Ander Regueiro, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

    Lluis A Serra, MD, +34 932 91 90 00, lasmarats@santpau.cat

    Lluis A Serra, MD

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

    Ángel S Recalde, MD, +34 913 36 80 00, asrecalde@hotmail.com

    Ángel S Recalde, MD

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

    Luis Nombela, MD, +34 913 30 30 00, luisnombela@yahoo.com

    Luis Nombela, MD

    Recruiting

  • Hospital Puerta De Hierro

    Majadahonda, 28222

    Juan Oteo, MD, +34 911 91 60 00, jf.oteo@gmail.com

    Juan Oteo, MD

    Recruiting

  • Hospital Virgen De La Victoria

    Málaga, 29010

    Juan Horacio A Briales, MD, +34 951 03 20 00, juanhalonso62@gmail.com

    Juan Horacio A Briales, MD

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

    Cesar Morís de La Tassa, MD, +34 985 10 80 00, cesarmoris@gmail.com

    Cesar Morís de la Tassa, MD

    Not yet recruiting

  • University Clinical Hospital of Valladolid

    Valladolid, Valladolid, 47003

    Ignacio J Amat-Santos, MD, +34 983 42 00 00, ijamat@gmail.com

    Ignacio J Amat-Santos, MD

    Recruiting

Other trials in Spain

Brazil5 sites, 5 recruiting

  • Instituto Nacional de Cardiologia

    Rio de Janeiro, Rio de Janeiro, 22240-006

    Cesar R Medeiros, MD, +55 21 2285-3344, cr.medeiros@terra.com.br

    Cesar R Medeiros, MD

    Not yet recruiting

  • Instituto Estadual De Cardiologia Aloysio De Castro

    Rio de Janeiro, 22261-010

    Marcio Jose Montenegro Da Costa, MD, marciojmontenegro@gmail.com

    Marcio Jose Montenegro Da Costa, MD

    Recruiting

  • Escola Paulista de Medicina da UNIFESP

    São Paulo, São Paulo, 04023-062

    Adriano M Caixeta, MD, +55 11 5576-4848, adriano.caixeta@unifesp.br

    Adriano M Caixeta, MD

    Not yet recruiting

  • Instituto Dante Pazzanese De Cardiologia

    São Paulo, 04012-909

    Dimytri Siqueira, MD, dimytrisiqueira@gmail.com

    Dimytri Siqueira, MD

    Recruiting

  • Instituto Do Coração (InCor) De São Paulo

    São Paulo, 05403-900

    Alexandre Abizaid, MD, aabizaid@uol.com.br

    Alexandre Abizaid, MD

    Recruiting

Other trials in Brazil

India5 sites, 5 recruiting

  • Narayana Health, Multispeciality Hospital

    Bangalore, 560099

    Sanjay Mehrotra, MD, info.nics@narayanahealth.org

    Sanjay Mehrotra, MD

    Not yet recruiting

  • Medanta - The Medicity Multi-Speciality Hospital

    Gūrgaon, 122001

    Praveen Chandra, MD, +91 124 414 1414, pravenn.chandra@medanta.org

    Praveen Chandra, MD

    Not yet recruiting

  • RHL- Rajasthan Hospital

    Jaipur, 302018

    Ravinder Singh Rao, MD, +91 141 272 0020, drravindersinghrao@yahoo.co.in

    Ravinder Singh Rao, MD

    Not yet recruiting

  • LISIE Hospital

    Kochi, 682017

    Rony Mathew Kadavil, MD, +91 484 240 2044, contact@lisiehospital.org

    Rony Mathew Kadavil, MD

    Not yet recruiting

  • Christian Medical College Hospital

    Vellore, 632 004

    John Jose E, MD, +91 8000338855, drjohnjose@gmail.com

    John Jose E, MD

    Not yet recruiting

Other trials in India

Portugal5 sites, 5 recruiting

  • Hospital de Santa Cruz

    Carnaxide, 2790-134

    João Brito, MD, +351 21 043 1000, jdbrito@chlo.min-saude.pt

    João Brito, MD

    Recruiting

  • Hospital do Espírito Santo de Évora

    Evora, Évora District, 7000-811

    Lino MR Patrício, MD, +351 266 740 100, linopatricio@gmail.com

    Lino MD Patrício, MD

    Not yet recruiting

  • Hospital Santa Marta

    Lisbon, Lisbon District, 1169-024

    Duarte Cacela, MD, +351 21 359 4000, duarte.cacela@chlc.min-saude.pt

    Duarte Cacela, MD

    Recruiting

  • Hospital Santa Maria

    Lisbon, Lisbon District, 1649-028

    Pedro C Ferreira, MD, +351 21 780 5000, pcarrilhoferreira@gmail.com

    Pedro C Ferreira, MD

    Recruiting

  • Unidade Local de Saúde de Gaia e Espinho

    Vila Nova de Gaia, 4434-502

    Pedro Braga, MD, +351 22 786 5100, jplpbraga@gmail.com

    Pedro Braga, MD

    Recruiting

Other trials in Portugal

Argentina3 sites, 3 recruiting

  • Hospital Privado Sur (FUMEBA)

    Bahía Blanca, B8000

    Alejandro Alvarez Iorio, MD, alexalv1970@gmail.com

    Alejandro Alvarez Iorio, MD

    Not yet recruiting

  • Fundación Favaloro

    Buenos Aires, C1093

    Oscar Mendiz, MD, omendiz@ffavaloro.org

    Oscar Mendiz, MD

    Not yet recruiting

  • Hospital Italiano De Buenos Aires

    Buenos Aires, C1199ABB

    Carla Agatiello, MD, carla.agatiello@hospitalitaliano.org.ar

    Carla Agatiello, MD

    Not yet recruiting

Other trials in Argentina

Chile3 sites, 3 recruiting

  • Hospital Del Torax De Santiago

    Santiago, 7500691

    Christian Dauvergne, cdauvergnem@yahoo.com

    Christian Dauvergne, MD

    Recruiting

  • Hospital Clínico San Borja Arriarán

    Santiago, 8360160

    Gabriel Maluenda, MD, +56 2 2574 9000, gabrielmaluenda@gmail.com

    Gabriel Maluenda, MD

    Recruiting

  • Hospital Las Higueras - Talcahuano

    Talcahuano, 4270940

    Osvaldo Perez, MD, osperez2000@gmail.com

    Osvaldo Perez, MD

    Recruiting

Other trials in Chile

Lithuania1 site, 1 recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, Kaunas County, 50161

    Kasparas Briedis, Dr

    Rimantas Benetis, Prof

    Recruiting

Other trials in Lithuania

Turkey (Türkiye)1 site, 1 recruiting

  • İ.A.Ü. VM Medical Park Florya Hospital

    Istanbul, Istanbul, 34295

    Hakan Ucar, MD, +90 4444484, ucarhakan2005@gmail.com

    Hakan Ucar, MD

    Not yet recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Vienna Aortic Valve SE System
Keywords
heart disease, aortic valve, SSAS, symptomatic severe aortic stenosis, heart valve
Medical subject headings
Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vienna Aortic Valve SE SystemDevice

    Vienna Aortic Valve SE system for TAVI.

Study groups in NCT04861805
Study groupRoleWhat they receive
Vienna Aortic ValveOthertranscatheter aortic valve implantation (TAVI)
Receives: Device: Vienna Aortic Valve SE System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cause Mortality (30 days)

    All-cause mortality at 30 days from the index procedure.

    Measured: up to 30 days

Secondary outcomes (14)

  1. All-cause, cardiovascular and non-cardiovascular mortality

    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.

    Measured: up to 5 years

  2. Periprocedural death

    Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death ≤72 h post-procedure)

    Measured: 72 hours

  3. Incidence of TAVI-related complications

    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)

    Measured: periprocedural and during index hospitalization

  4. Cerebrovascular event

    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.

    Measured: Up to 5 years

  5. Life-threatening bleeding

    Life-threatening bleeding (at 30 days, 3 months, 6 months and 1 year post-implantation).

    Measured: Up to 1 year

  6. Conduction disturbances requiring permanent pacemaker implantation

    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)

    Measured: Up to 5 years

  7. Rehospitalization

    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)

    Measured: Up to 5 years

  8. Device Success

    Device success defined as:

    1. 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

    Measured: 72 hours

  9. Technical success

    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:
    4. Total aortic regurgitation of none/trace/mild/mild-moderate
    5. Patient prosthesis mismatch (PPM) insignificant*
    6. Mean gradient < 20 mmHg

    Measured: up to 30 days

  10. Clinical Efficacy

    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)

    Measured: 1 year

  11. Valve-related clinical efficacy

    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)

    Measured: Up to 5 years

  12. New York Heart Association (NYHA) classification

    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)

    Measured: Up to 5 years

  13. Change in quality of life as assessed by the Kansas City Cardiomyopathy

    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

    Measured: 1 year

  14. Change in exercise capacity measured as the 6-minute walk distance (6-MWD)

    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)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start3 Jul 2023
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective, single arm, multicenter pivotal study in an expanding cohort of symptomatic patients with severe aortic stenosis (following the initial FIH feasibility study).
Masking
None (open label)
Enrolment
267 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04861805
Sponsor's protocol ID
CTP-VIE-001
Acronym
VIVA
Status last verified
Jun 2025
First submitted
20 Apr 2021
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Briedis K, Rumbinaite E, Aldujeli A, Briede K, Jurenas M, Jakuska P, Jankauskas A, Ceponiene I, Lenkutis T, Plisiene J, Benetis R, Zaliunas R. One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study. Catheter Cardiovasc Interv. 2024 Jun;103(7):1111-1124. doi: 10.1002/ccd.31039. Epub 2024 Apr 9.

    PubMed 38591535

  • Briedis K, Aldujeli A, Zaliunas R, Benetis R. Early Safety and Performance of the Premounted Dry-Pericardium Vienna Self-Expandable Transcatheter Aortic Valve System: 30-Day Outcomes of the First-in-Human VIVA Feasibility Study. Am J Cardiol. 2023 Oct 1;204:302-311. doi: 10.1016/j.amjcard.2023.07.109. Epub 2023 Aug 9.

    PubMed 37567022

  • Briedis K, Mizariene V, Rumbinaite E, Jurenas M, Aldujeli A, Briede K, Jakuska P, Jankauskas A, Ceponiene I, Lenkutis T, Zaliunas R, Benetis R. Safety and performance of the Vienna self-expandable transcatheter aortic valve system: 6-month results of the VIVA first-in-human feasibility study. Front Cardiovasc Med. 2023 Jul 13;10:1199047. doi: 10.3389/fcvm.2023.1199047. eCollection 2023.

    PubMed 37522086

Questions about this trial

What is this clinical trial studying?

A study testing Vienna Aortic Valve SE System in people with Symptomatic Aortic Stenosis, run by P+F Products + Features GmbH at 31 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Spain, Brazil, India, Portugal, Argentina and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katharina Kiss, Dr (+4369913289414, kkiss@productsandfeatures.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause Mortality (30 days) (time frame: up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04861805, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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