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

June 25, 2025 updated by: P+F Products + Features GmbH

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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The clinical trial is completed after all 267 patients, that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments.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

Interventional

Enrollment (Estimated)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, B8000
        • Not yet recruiting
        • Hospital Privado Sur (FUMEBA)
        • Contact:
        • Principal Investigator:
          • Alejandro Alvarez Iorio, MD
      • Buenos Aires, Argentina, C1199ABB
      • Buenos Aires, Argentina, C1093
        • Not yet recruiting
        • Fundacion Favaloro
        • Contact:
        • Principal Investigator:
          • Oscar Mendiz, MD
  • Brazil
      • Rio de Janeiro, Brazil, 22240-006
        • Not yet recruiting
        • Instituto Nacional de Cardiologia
        • Contact:
        • Principal Investigator:
          • Cesar R Medeiros, MD
      • Rio de Janeiro, Brazil, 22261-010
        • Recruiting
        • Instituto Estadual de Cardiologia Aloysio de Castro
        • Contact:
        • Principal Investigator:
          • Marcio Jose Montenegro Da Costa, MD
      • São Paulo, Brazil, 04012-909
        • Recruiting
        • Instituto Dante Pazzanese de Cardiologia
        • Contact:
        • Principal Investigator:
          • Dimytri Siqueira, MD
      • São Paulo, Brazil, 04023-062
        • Not yet recruiting
        • Escola Paulista de Medicina da UNIFESP
        • Contact:
        • Principal Investigator:
          • Adriano M Caixeta, MD
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Instituto Do Coração (InCor) De São Paulo
        • Contact:
        • Principal Investigator:
          • Alexandre Abizaid, MD
  • Chile
      • Santiago, Chile, 7500691
        • Recruiting
        • Hospital Del Torax De Santiago
        • Principal Investigator:
          • Christian Dauvergne, MD
        • Contact:
      • Santiago, Chile, 8360160
        • Recruiting
        • Hospital Clinico San Borja Arriaran
        • Contact:
        • Principal Investigator:
          • Gabriel Maluenda, MD
      • Talcahuano, Chile, 4270940
        • Recruiting
        • Hospital Las Higueras - Talcahuano
        • Contact:
        • Principal Investigator:
          • Osvaldo Perez, MD
  • India
      • Bangalore, India, 560099
        • Not yet recruiting
        • Narayana Health, Multispeciality Hospital
        • Contact:
        • Principal Investigator:
          • Sanjay Mehrotra, MD
      • Gurgaon, India, 122001
        • Not yet recruiting
        • Medanta - The Medicity Multi-Speciality Hospital
        • Contact:
        • Principal Investigator:
          • Praveen Chandra, MD
      • Jaipur, India, 302018
        • Not yet recruiting
        • RHL- Rajasthan Hospital
        • Contact:
        • Principal Investigator:
          • Ravinder Singh Rao, MD
      • Kochi, India, 682017
        • Not yet recruiting
        • Lisie Hospital
        • Contact:
        • Principal Investigator:
          • Rony Mathew Kadavil, MD
      • Vellore, India, 632 004
        • Not yet recruiting
        • Christian Medical College Hospital
        • Contact:
        • Principal Investigator:
          • John Jose E, MD
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • Contact:
          • Kasparas Briedis, Dr
        • Principal Investigator:
          • Rimantas Benetis, Prof
  • Portugal
      • Carnaxide, Portugal, 2790-134
        • Recruiting
        • Hospital de Santa Cruz
        • Contact:
        • Principal Investigator:
          • João Brito, MD
      • Lisboa, Portugal, 1169-024
        • Recruiting
        • Hospital Santa Marta
        • Contact:
        • Principal Investigator:
          • Duarte Cacela, MD
      • Lisboa, Portugal, 1649-028
        • Recruiting
        • Hospital Santa Maria
        • Contact:
        • Principal Investigator:
          • Pedro C Ferreira, MD
      • Vila Nova de Gaia, Portugal, 4434-502
        • Recruiting
        • Unidade Local de Saúde de Gaia e Espinho
        • Contact:
        • Principal Investigator:
          • Pedro Braga, MD
      • Évora, Portugal, 7000-811
        • Not yet recruiting
        • Hospital do Espírito Santo de Évora
        • Contact:
        • Principal Investigator:
          • Lino MD Patrício, MD
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
        • Principal Investigator:
          • Ander Regueiro, MD
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Principal Investigator:
          • Lluis A Serra, MD
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Principal Investigator:
          • Ángel S Recalde, MD
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
        • Principal Investigator:
          • Luis Nombela, MD
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Puerta de Hierro
        • Contact:
        • Principal Investigator:
          • Juan Oteo, MD
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Virgen de la Victoria
        • Contact:
        • Principal Investigator:
          • Juan Horacio A Briales, MD
      • Oviedo, Spain, 33011
        • Not yet recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Cesar Morís de la Tassa, MD
      • Valladolid, Spain, 47003
        • Recruiting
        • University Clinical Hospital of Valladolid
        • Contact:
          • Ignacio J Amat-Santos, MD
          • Phone Number: +34 983 42 00 00
          • Email: ijamat@gmail.com
        • Principal Investigator:
          • Ignacio J Amat-Santos, MD
  • Turkey
      • Istanbul, Turkey, 34295
        • Not yet recruiting
        • İ.A.Ü. VM Medical Park Florya Hospital
        • Contact:
        • Principal Investigator:
          • Hakan Ucar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vienna Aortic Valve
transcatheter aortic valve implantation (TAVI)
Device: Vienna Aortic Valve SE System
Vienna Aortic Valve SE system for TAVI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause Mortality (30 days)
Time Frame: up to 30 days
All-cause mortality at 30 days from the index procedure.
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause, cardiovascular and non-cardiovascular mortality
Time Frame: 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.
up to 5 years
Periprocedural death
Time Frame: 72 hours
Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death ≤72 h post-procedure)
72 hours
Incidence of TAVI-related complications
Time Frame: 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)
periprocedural and during index hospitalization
Cerebrovascular event
Time Frame: 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.
Up to 5 years
Life-threatening bleeding
Time Frame: Up to 1 year
Life-threatening bleeding (at 30 days, 3 months, 6 months and 1 year post-implantation).
Up to 1 year
Conduction disturbances requiring permanent pacemaker implantation
Time Frame: 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)
Up to 5 years
Rehospitalization
Time Frame: 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
Time Frame: 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
72 hours
Technical success
Time Frame: 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
up to 30 days
Clinical Efficacy
Time Frame: 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)
1 year
Valve-related clinical efficacy
Time Frame: 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)
Up to 5 years
New York Heart Association (NYHA) classification
Time Frame: 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
Change in quality of life as assessed by the Kansas City Cardiomyopathy
Time Frame: 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
1 year
Change in exercise capacity measured as the 6-minute walk distance (6-MWD)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

P+F Products + Features GmbH

Collaborators

Meditrial USA Inc.

Investigators

  • Principal Investigator: Alexandre Abizaid, MD, Instituto Do Coração (InCor) De São Paulo
  • Principal Investigator: Carla Agatiello, MD, Hospital Italiano de Buenos Aires
  • Principal Investigator: Alejandro Alvarez Iorio, MD, Hospital Privado Sur (FUMEBA)
  • Principal Investigator: Ignacio J Amat-Santos, MD, University Clinical Hospital of Valladolid
  • Principal Investigator: Rimantas Benetis, MD, Lithuanian University of Health Sciences
  • Principal Investigator: Pedro Braga, MD, Unidade Local de Saúde de Gaia e Espinho
  • Principal Investigator: Juan Horacio A Briales, MD, Hospital Virgen de la Victoria
  • Principal Investigator: João Brito, MD, Hospital de Santa Cruz
  • Principal Investigator: Duarte Cacela, MD, Hospital Santa Marta
  • Principal Investigator: Adriano M Caixeta, MD, Escola Paulista de Medicina da UNIFESP
  • Principal Investigator: Praveen Chandra, MD, Medanta - The Medicity Hospital
  • Principal Investigator: Christian Dauvergne, MD, Hospital Del Torax De Santiago
  • Principal Investigator: Pedro C Ferreira, MD, Hospital Santa Maria
  • Principal Investigator: John Jose E, MD, Christian Medical College Hospital
  • Principal Investigator: Rony Mathew Kadavil, MD, Lisie Hospital
  • Principal Investigator: Gabriel Maluenda, MD, Hospital Clinico San Borja Arriaran
  • Principal Investigator: Cesar R Medeiros, MD, Instituto Nacional de Cardiologia
  • Principal Investigator: Oscar Mendiz, MD, Fundacion Favaloro
  • Principal Investigator: Sanjay Mehrotra, MD, Narayana Health Hospital
  • Principal Investigator: Marcio J Montenegro Da Costa, MD, Instituto Estadual de Cardiologia Aloysio de Castro
  • Principal Investigator: Cesar Morís de La Tassa, MD, Hospital Universitario Central de Asturias
  • Principal Investigator: Luis Nombela, MD, Hospital San Carlos, Madrid
  • Principal Investigator: Juan Oteo, MD, Hospital Puerta de Hierro
  • Principal Investigator: Lino MD Patrício, MD, Hospital do Espírito Santo de Évora
  • Principal Investigator: Osvaldo Perez, MD, Hospital Las Higueras - Talcahuano
  • Principal Investigator: Ravinder Singh Rao, MD, RHL - Rajasthan Hospital
  • Principal Investigator: Ángel S Recalde, MD, Hospital Universitario Ramon y Cajal
  • Principal Investigator: Ander Regueiro, MD, Hospital Clinic of Barcelona
  • Principal Investigator: Lluis A Serra, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Principal Investigator: Dimytri Siqueira, MD, Instituto Dante Pazzanese de Cardiologia
  • Principal Investigator: Hakan Ucar, MD, İ.A.Ü. VM Medical Park Florya Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-VIE-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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