2026-03-25
minor
Study Status, Contacts/Locations, Outcome Measures (Results) v14
Results first postednot stated→2026-04-13
Study sitesdetails revised at 8 of 37 sites
2026-02-19
minor
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v13
Secondary endpointsdetails revised at 1 of 3 entries
Primary endpoints2 entries, revised
Primary Effectiveness Endpoint: The RatePercentage of Participants With Moderate or Greater Paravalvular Leak (PVL)
2026-01-08
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v12
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2025-06-30→confirmed 2025-01-02
Start date2021-06-13→2021-07-13
Enrollment targetestimated 590→confirmed 434
Study sites39→37
InterventionsNavitor Transcatheter Aortic Valve and FlexNav Delivery System (Device)→Navitor Transcatheter Aortic valve and FlexNav Delivery system (Device)
Secondary endpoints3 entries, revised
Mean Change in Mean Transvalvular gradientGradient
Mean Change in Effective orificeOrifice areaArea (EOA)
Mean Change In KCCQ qualityQuality ofOf lifeLife scoreScore
Primary endpoints2 entries, revised
IncidencePrimary Effectiveness Endpoint: The Rate of a composite of all-cause mortalityModerate or fatalGreater stroke/strokeParavalvular with disability at 12 monthsLeak (PVL)
Primary Safety Endpoint)
: The proportionRates of subjectsAll-cause who have moderateMortality or greaterFatal paravalvularStroke/Stroke leakWith at 30 days (Primary Effectiveness Endpoint)Disability
Show 9 earlier versions
2024-09-13
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 37 of 38 sites
2024-01-05
minor
Study Status, Contacts/Locations v8
2023-08-24
minor
Study Status, Outcome Measures, Contacts/Locations v7
Primary endpoints2 entries, revised
Incidence of a composite of all-cause mortality or fatal stroke/stroke with disability at 12 months (Primary Safety Endpoint)
The proportion of subjects who have moderate or greater paravalvular leak at 30 days (Primary Effectiveness Endpoint
Primary Safety Endpoint)
2023-07-25
minor
Study Status, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2025-04-30→2025-06-30
Study sites22→30
Eligibility criteria+1,873 characters
Inclusion Criteria:
InSubject thewho judgementis ofjudged theby site'sa Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart teamvalve intervention therapy, subjectand is deemed to be at intermediate or low risk for open surgic [...] er clinical co-morbidities unmeasured by the risk calculator).
*
New York Heart Association (NYHA) Functional Classification of II, III, or IV *
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 [...] [...]
Secondary endpoints+72 characters
Transvalvular gradient
Effective orifice area
KCCQ quality of life score
Primary endpoints1 to 2 entries
Primary safetyEffectiveness andEndpoint
Primary effectivenessSafety endpoint is a composite of all-cause mortality or disabling strokeEndpoint
2023-01-06
minor
Study Status, Contacts/Locations v5
2022-05-11
minor
Study Status, Study Design, Contacts/Locations v4
Enrollment target550→590
Study sites13→21
2022-01-21
minor
Study Status, Contacts/Locations v3
Primary completion date2023-03-31→2025-04-30
Completion date2033-12-31→2036-02-28
Study sites3→13
2021-08-08
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-06-30→confirmed 2021-06-13
Study sites0→3
Study description+315 characters
The VANTAGE clinical trial will evaluate the safety and effectiveness of the Navitor valve in patients with severe, symptomatic aortic stenosis who are at intermediate or low risk of surgical mortality.
This trial will also evaluate the safety and effectiveness of the Navitor valve in a valve-in-val [...]
2021-04-09
minor
Study Status, Eligibility v1
Eligibility criteria-5,714 characters
[...] ociation (NYHA) Functional Classification of II, III, or IV
Subject is of legal age for consent in the host country
Subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) or Ethics Committee (EC) of the respective clinical site
Able and willi [...] Exclusion Criteria:
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
A pregnancy test is required for all women of childbearing potential.
Need for emergency surgery for any reaso [...] [...]