MedDataX Logo

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

NCT ID: NCT04861805

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2030-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transcatheter Aortic Valve Replacement System Pivotal Trial

NCT02163850

Aortic Valve Stenosis
UNKNOWN NA

CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.

NCT03752866

Symptomatic Degenerative Aortic Stenosis Severe Aortic Stenosis
COMPLETED NA

VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

NCT04655742

Aortic Valve Stenosis
UNKNOWN NA

FlexNav EU CE Mark Study

NCT03724812

Symptomatic Severe Aortic Stenosis
COMPLETED NA

Engager Direct Aortic Clinical Study

NCT01789567

Aortic Valve Stenosis
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Symptomatic Aortic Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vienna Aortic Valve

transcatheter aortic valve implantation (TAVI)

Group Type OTHER

Vienna Aortic Valve SE System

Intervention Type DEVICE

Vienna Aortic Valve SE system for TAVI.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vienna Aortic Valve SE System

Vienna Aortic Valve SE system for TAVI.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meditrial USA Inc.

INDUSTRY

Sponsor Role collaborator

P+F Products + Features GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexandre Abizaid, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coração (InCor) de São Paulo

Carla Agatiello, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Alejandro Alvarez Iorio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privado Sur (FUMEBA)

Ignacio J Amat-Santos, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinical Hospital of Valladolid

Rimantas Benetis, MD

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences

Pedro Braga, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Local de Saúde de Gaia e Espinho

Juan Horacio A Briales, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Victoria

João Brito, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Santa Cruz

Duarte Cacela, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Santa Marta

Adriano M Caixeta, MD

Role: PRINCIPAL_INVESTIGATOR

Escola Paulista de Medicina da UNIFESP

Praveen Chandra, MD

Role: PRINCIPAL_INVESTIGATOR

Medanta - The Medicity Hospital

Christian Dauvergne, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Tórax de Santiago

Pedro C Ferreira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Santa Maria

John Jose E, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College Hospital

Rony Mathew Kadavil, MD

Role: PRINCIPAL_INVESTIGATOR

Lisie Hospital

Gabriel Maluenda, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico San Borja Arriarán

Cesar R Medeiros, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiologia

Oscar Mendiz, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Favaloro

Sanjay Mehrotra, MD

Role: PRINCIPAL_INVESTIGATOR

Narayana Health Hospital

Marcio J Montenegro Da Costa, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Estadual de Cardiologia Aloysio de Castro

Cesar Morís de La Tassa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Central de Asturias

Luis Nombela, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Carlos, Madrid

Juan Oteo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta De Hierro

Lino MD Patrício, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Espírito Santo de Évora

Osvaldo Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Las Higueras - Talcahuano

Ravinder Singh Rao, MD

Role: PRINCIPAL_INVESTIGATOR

RHL - Rajasthan Hospital

Ángel S Recalde, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Ander Regueiro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Lluis A Serra, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Dimytri Siqueira, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Hakan Ucar, MD

Role: PRINCIPAL_INVESTIGATOR

İ.A.Ü. VM Medical Park Florya Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Privado Sur (FUMEBA)

Bahía Blanca, , Argentina

Site Status NOT_YET_RECRUITING

Fundación Favaloro

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Hospital Italiano De Buenos Aires

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status NOT_YET_RECRUITING

Escola Paulista de Medicina da UNIFESP

São Paulo, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Instituto Estadual De Cardiologia Aloysio De Castro

Rio de Janeiro, , Brazil

Site Status RECRUITING

Instituto Dante Pazzanese De Cardiologia

São Paulo, , Brazil

Site Status RECRUITING

Instituto Do Coração (InCor) De São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Hospital Del Torax De Santiago

Santiago, , Chile

Site Status RECRUITING

Hospital Clínico San Borja Arriarán

Santiago, , Chile

Site Status RECRUITING

Hospital Las Higueras - Talcahuano

Talcahuano, , Chile

Site Status RECRUITING

Narayana Health, Multispeciality Hospital

Bangalore, , India

Site Status NOT_YET_RECRUITING

Medanta - The Medicity Multi-Speciality Hospital

Gurgaon, , India

Site Status NOT_YET_RECRUITING

RHL- Rajasthan Hospital

Jaipur, , India

Site Status NOT_YET_RECRUITING

LISIE Hospital

Kochi, , India

Site Status NOT_YET_RECRUITING

Christian Medical College Hospital

Vellore, , India

Site Status NOT_YET_RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Kaunas County, Lithuania

Site Status RECRUITING

Hospital Santa Marta

Lisbon, Lisbon District, Portugal

Site Status RECRUITING

Hospital Santa Maria

Lisbon, Lisbon District, Portugal

Site Status RECRUITING

Hospital de Santa Cruz

Carnaxide, , Portugal

Site Status RECRUITING

Unidade Local de Saúde de Gaia e Espinho

Vila Nova de Gaia, , Portugal

Site Status RECRUITING

Hospital do Espírito Santo de Évora

Evora, Évora District, Portugal

Site Status NOT_YET_RECRUITING

Hospital Clinic De Barcelona

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Site Status RECRUITING

University Clinical Hospital of Valladolid

Valladolid, Valladolid, Spain

Site Status RECRUITING

Hospital Puerta De Hierro

Majadahonda, , Spain

Site Status RECRUITING

Hospital Virgen De La Victoria

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status NOT_YET_RECRUITING

İ.A.Ü. VM Medical Park Florya Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Argentina Brazil Chile India Lithuania Portugal Spain Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Katharina Kiss, Dr

Role: CONTACT

[email protected]
+4369913289414

Monica Tocchi, MD, PhD

Role: CONTACT

[email protected]
9176841700

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alejandro Alvarez Iorio, MD

Role: primary

[email protected]

Oscar Mendiz, MD

Role: primary

[email protected]

Carla Agatiello, MD

Role: primary

[email protected]

Cesar R Medeiros, MD

Role: primary

[email protected]
+55 21 2285-3344

Adriano M Caixeta, MD

Role: primary

[email protected]
+55 11 5576-4848

Marcio Jose Montenegro Da Costa, MD

Role: primary

[email protected]

Dimytri Siqueira, MD

Role: primary

[email protected]

Alexandre Abizaid, MD

Role: primary

[email protected]

Christian Dauvergne

Role: primary

[email protected]

Gabriel Maluenda, MD

Role: primary

[email protected]
+56 2 2574 9000

Osvaldo Perez, MD

Role: primary

[email protected]

Sanjay Mehrotra, MD

Role: primary

[email protected]

Praveen Chandra, MD

Role: primary

[email protected]
+91 124 414 1414

Ravinder Singh Rao, MD

Role: primary

[email protected]
+91 141 272 0020

Rony Mathew Kadavil, MD

Role: primary

[email protected]
+91 484 240 2044

John Jose E, MD

Role: primary

[email protected]
+91 8000338855

Kasparas Briedis, Dr

Role: primary

Duarte Cacela, MD

Role: primary

[email protected]
+351 21 359 4000

Pedro C Ferreira, MD

Role: primary

[email protected]
+351 21 780 5000

João Brito, MD

Role: primary

[email protected]
+351 21 043 1000

Pedro Braga, MD

Role: primary

[email protected]
+351 22 786 5100

Lino MR Patrício, MD

Role: primary

[email protected]
+351 266 740 100

Ander Regueiro, MD

Role: primary

[email protected]
+34 932 27 54 00

Lluis A Serra, MD

Role: primary

[email protected]
+34 932 91 90 00

Ángel S Recalde, MD

Role: primary

[email protected]
+34 913 36 80 00

Luis Nombela, MD

Role: primary

[email protected]
+34 913 30 30 00

Ignacio J Amat-Santos, MD

Role: primary

[email protected]
+34 983 42 00 00

Juan Oteo, MD

Role: primary

[email protected]
+34 911 91 60 00

Juan Horacio A Briales, MD

Role: primary

[email protected]
+34 951 03 20 00

Cesar Morís de La Tassa, MD

Role: primary

[email protected]
+34 985 10 80 00

Hakan Ucar, MD

Role: primary

[email protected]
+90 4444484

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38591535 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37567022 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37522086 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://productsandfeatures.com/

Products \& Features, manufacturer of VIVA Transcatheter Aortic Valve System

http://meditrial.com

Meditrial Clinical Research Organization

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTP-VIE-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
NCT04414878 RECRUITING NA
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
NCT00530894 COMPLETED NA
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
NCT07116551 RECRUITING NA
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
NCT05479305 RECRUITING NA
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
NCT01808274 COMPLETED NA
PERIGON Pivotal Trial
NCT02088554 ACTIVE_NOT_RECRUITING NA
Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Delivery System for the Treatment of Severe Aortic Stenosis Lesions
NCT07145463 RECRUITING NA
BIOVALVE - I / II Clincial Investigation
NCT02249000 COMPLETED NA
Evaluation of the Zilver® Vena™ Venous Stent
NCT01663051 COMPLETED
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
NCT03618095 TERMINATED NA
Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/dissection of the Descending Thoracic Aorta
NCT03735472 COMPLETED
The Arterial Revascularization Therapies Study Part II.
NCT00235170 COMPLETED PHASE3
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
NCT03246126 COMPLETED NA
VitaFlowTM II Transcatheter Aortic Valve System Study
NCT03575039 UNKNOWN NA
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
NCT06872905 RECRUITING
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
NCT03517436 ACTIVE_NOT_RECRUITING NA
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
NCT03471065 COMPLETED NA
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
NCT05977257 NOT_YET_RECRUITING
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
NCT05378347 RECRUITING NA
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
NCT04843072 RECRUITING NA
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
NCT06605209 RECRUITING NA
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
NCT05143138 ACTIVE_NOT_RECRUITING
Enable I Long-term Follow-up Study
NCT01636648 TERMINATED
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
NCT02184442 COMPLETED NA
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
NCT02458560 COMPLETED NA