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.
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
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
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- 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).
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- 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.
31 sites in 8 countries
Spain8 sites, 8 recruiting
- 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
- Not yet 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
- 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
Brazil5 sites, 5 recruiting
- Not yet 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
- 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
- Not yet 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
- 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
India5 sites, 5 recruiting
- Not yet 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
Portugal5 sites, 5 recruiting
- Recruiting
Hospital de Santa Cruz
Carnaxide, 2790-134
João Brito, MD, +351 21 043 1000, jdbrito@chlo.min-saude.pt
João Brito, MD
- Not yet 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
- 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
Argentina3 sites, 3 recruiting
- Not yet 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
Chile3 sites, 3 recruiting
- 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
Lithuania1 site, 1 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Kaunas County, 50161
Kasparas Briedis, Dr
Rimantas Benetis, Prof
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
İ.A.Ü. VM Medical Park Florya Hospital
Istanbul, Istanbul, 34295
Hakan Ucar, MD, +90 4444484, ucarhakan2005@gmail.com
Hakan Ucar, MD
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.
- Conditions
- Symptomatic Aortic Stenosis
- 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 group | Role | What they receive |
|---|---|---|
| Vienna Aortic Valve | Other | transcatheter 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.
All Cause Mortality (30 days)
All-cause mortality at 30 days from the index procedure.
Measured: up to 30 days
Secondary outcomes (14)
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
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
Incidence of TAVI-related complications
Incidence of TAVI-related complications:
- Valve-related complication requiring repeat procedure
- Vascular complications resulting in interventions
- Ventricular septal perforation ≤7 days after IMD implantation
- Acute kidney injury-Stage 2 or 3 ≤7 days post IMD implantation
- Coronary artery obstruction requiring intervention
- Atrio-ventricular block requiring pacemaker implantation
- Mitral valve apparatus damage or dysfunction
- Evidence of a new pericardial effusion/ tamponade related to the TAVI procedure
- Prosthetic valve endocarditis
- Prosthetic valve thrombosis
- Prosthetic valve mispositioning
- Prosthetic valve embolization
- 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
Cerebrovascular event
Cerebrovascular event (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation):
- 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
- 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
Life-threatening bleeding
Life-threatening bleeding (at 30 days, 3 months, 6 months and 1 year post-implantation).
Measured: Up to 1 year
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
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
Device Success
Device success defined as:
- 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
Technical success
Technical success defined as
- successful vascular access, delivery and deployment of the IMD and successful retrieval of the delivery system; and
- correct positioning of a single prosthetic investigational heart valve in the proper anatomical location
- in patients alive at 30 days with implanted Vienna valve:
- Total aortic regurgitation of none/trace/mild/mild-moderate
- Patient prosthesis mismatch (PPM) insignificant*
- Mean gradient < 20 mmHg
Measured: up to 30 days
Clinical Efficacy
Clinical efficacy (at 1 year and thereafter)
- Freedom from all-cause mortality
- Freedom from all stroke
- Freedom from hospitalization for procedure- or valve-related causes
- Freedom from KCCQ Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)
Measured: 1 year
Valve-related clinical efficacy
Valve-related clinical efficacy
- Freedom from bioprosthetic Valve Failure (defined as: Valve-related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 haemodynamic valve deterioration)
- Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
- 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
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
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
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.
- First posted27 Apr 2021
- Study start3 Jul 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- P+F Products + Features GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Responsible party
- Sponsor
- Investigators
- Alexandre Abizaid, MD, Principal investigator, Instituto do Coração (InCor) de São PauloCarla Agatiello, MD, Principal investigator, Hospital Italiano de Buenos AiresAlejandro Alvarez Iorio, MD, Principal investigator, Hospital Privado Sur (FUMEBA)Ignacio J Amat-Santos, MD, Principal investigator, University Clinical Hospital of ValladolidRimantas Benetis, MD, Principal investigator, Lithuanian University of Health SciencesPedro Braga, MD, Principal investigator, Unidade Local de Saúde de Gaia e EspinhoJuan Horacio A Briales, MD, Principal investigator, Hospital Virgen de la VictoriaJoão Brito, MD, Principal investigator, Hospital de Santa Cruz
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 38591535Briedis 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 37567022Briedis 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