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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04788888
Registration number
NCT04788888
Ethics application status
Date submitted
2/03/2021
Date registered
9/03/2021
Date last updated
8/01/2024
Titles & IDs
Public title
Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
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Scientific title
VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
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Secondary ID [1]
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ABT-CIP-10342
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Universal Trial Number (UTN)
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Trial acronym
VANTAGE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Symptomatic Severe Aortic Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Navitor Transcatheter Aortic Valve and FlexNav Delivery System
Experimental: Navitor Transcatheter Aortic Valve, FlexNav Delivery System - Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and and Navitor Loading System (small, large, and LG+)
Treatment: Devices: Navitor Transcatheter Aortic Valve and FlexNav Delivery System
For traditional application, the Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
For the valve-in-valve application, the Navitor valve is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve.
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of a composite of all-cause mortality or fatal stroke/stroke with disability at 12 months (Primary Safety Endpoint)
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Assessment method [1]
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A composite of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure per the Valve Academic Research Consortium (VARC) 3 event definitions
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Timepoint [1]
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12 months post index procedure
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Primary outcome [2]
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The proportion of subjects who have moderate or greater paravalvular leak at 30 days (Primary Effectiveness Endpoint)
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Assessment method [2]
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Moderate or greater paravalvular leak at 30 days
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Timepoint [2]
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30 days post index procedure
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Secondary outcome [1]
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Transvalvular gradient
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Assessment method [1]
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Mean change in mean transvalvular gradient between baseline and 12 months
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Timepoint [1]
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12 months post index procedure
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Secondary outcome [2]
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Effective orifice area
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Assessment method [2]
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Mean change in effective orifice area between baseline and 12 months
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Timepoint [2]
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12 months post index procedure
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Secondary outcome [3]
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KCCQ quality of life score
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Assessment method [3]
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Mean change in KCCQ quality of life score between baseline and 12 months
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Timepoint [3]
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12 months post index procedure
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Eligibility
Key inclusion criteria
1. Subject who is judged by a Heart Team, including a cardiac surgeon, to be appropriate
for transcatheter heart valve intervention therapy, and is deemed to be at
intermediate or low risk for open surgical aortic valve replacement (i.e., heart team
estimates risk of surgical mortality < 7% at 30 days, considering the Society of
Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical
co-morbidities unmeasured by the risk calculator). *
2. New York Heart Association (NYHA) Functional Classification of II, III, or IV *
3. Degenerative aortic valve stenosis with echo-derived criteria, defined as:
aortic valve area (AVA) of = 1.0 cm2 (or indexed EOA = 0.6 cm2/m2) AND either mean
gradient = 40 mmHg or peak jet velocity = 4.0 m/s or doppler velocity index (DVI) =
0.25. The echocardiogram supporting the qualifying AVA baseline measurement must be
performed within 90 days prior to informed consent). *
4. Aortic annulus diameter of 19-30 mm and ascending aorta diameter of 26-44 mm for the
specified valve size listed in the IFU, as measured by CT (systolic phase) conducted
within 12 months prior to informed consent.
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Life expectancy is less than 2 years in the opinion of the Investigator.
2. Evidence of an acute myocardial infarction [defined as ST-segment elevation myocardial
infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with
acute ischemia symptoms and troponin elevation] within 30 days prior to index
procedure.
3. Untreated clinically significant coronary artery disease requiring revascularization.
4. Any percutaneous coronary or peripheral interventional procedure performed within 30
days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant)
to index procedure or planned within 30 days following the index procedure.
5. Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 g/dL),
thrombocytopenia (platelet count < 50,000 cells/mm³); history of bleeding diathesis or
coagulopathy
6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that
would preclude anticoagulation
7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA)
or a transient ischemic attack (TIA)
8. Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/ or end
stage renal disease requiring chronic dialysis
9. Hostile chest or conditions or complications from prior surgery that would make the
subject be considered high surgical risk (i.e., mediastinitis, radiation damage,
abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to
sternum, etc.) *
10. Significant frailty as determined by the heart team (after objective assessment of
frailty parameters) that would indicate high or extreme surgical risk *
11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation 3-4+) *
12. Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified by
echocardiography or CT *
13. Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram
14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or
transcatheter edge-to-edge repair (TEER) clip) in any valve position * (Note: Subjects
with a bioprosthetic aortic valve may be included in the ViV cohort.)
15. Severe circumferential mitral annular calcification (MAC) which is continuous with
calcium in the left ventricular outflow tract (LVOT) *
16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
with pulmonary compromise
17. Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5
mm for large FlexNav Delivery System
18. Eccentricity ratio of the annulus < 0.73
- Criterion not applicable for valve-in-valve application
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/02/2036
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Actual
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Sample size
Target
590
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St. Andrew's Hospital - Adelaide
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Fiona Stanley Hospital - Murdoch
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Macquirie University Hopsital - Ryde
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Prince of Wales Hospital - Sydney
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment postcode(s) [3]
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WA 6150 - Murdoch
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Recruitment postcode(s) [4]
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- Ryde
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Recruitment postcode(s) [5]
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NSW 2031 - Sydney
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Recruitment postcode(s) [6]
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QLD 4102, - Woolloongabba
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Recruitment outside Australia
Country [1]
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Austria
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Graz
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Austria
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Linz
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Austria
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Vienna
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Denmark
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Copenhagen
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France
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Clermont-Ferrand
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France
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Pessac
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France
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Toulouse
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Germany
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Bad Nauheim
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Germany
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Berlin
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Germany
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Dortmund
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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München
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Italy
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Caserta
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Italy
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Padua
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Italy
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Milan
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Rotterdam
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Switzerland
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Zürich
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United Kingdom
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Belfast
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Evaluation of TAVR using the NAVITOR valve in a Global Investigation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04788888
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Worthley, M.D., Ph. D.
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Address
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Macquarie University Hospital
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Email
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Contact person for public queries
Name
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Nadia Bouhdi
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Address
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Phone
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+32 479 94 10 37
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04788888
Download to PDF