Symptomatic Severe Aortic StenosisVANTAGENCT04788888
Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
A study testing Navitor Transcatheter Aortic valve and FlexNav Delivery system in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 37 sites in 11 countries.
Trial summary
Evaluation of TAVR using the NAVITOR valve in a Global Investigation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- Navitor Transcatheter Aortic valve and FlexNav Delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 37 sitesin 11 countries
- Study dates
- 13 Jul 2021to 28 Feb 2036
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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). *
- 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 ≥ 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).
- 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.
Who cannot join
- Life expectancy is less than 2 years in the opinion of the Investigator.
- 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.
- Untreated clinically significant coronary artery disease requiring revascularization.
- 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.
- 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
- Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
Show all 19Show fewer
- Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
- Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/ or end stage renal disease requiring chronic dialysis
- 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.) *
- Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk *
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+) *
- Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified by echocardiography or CT *
- Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram
- 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.)
- Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT) *
- Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis with pulmonary compromise
- Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System
- Eccentricity ratio of the annulus < 0.73
- Criterion not applicable for valve-in-valve application
Trial locations and contacts
37 sites in 11 countries.
37 sites in 11 countries
Germany8 sites
Kerckhoff-Klinik GgmbH
Bad Nauheim
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
Berlin
St. Johannes-Hospital
Dortmund
Herzzentrum Dresden
Dresden
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg
Herzzentrum Leipzig GmbH
Leipzig
DHZ München
München
Australia6 sites
St. Andrew's Hospital
Adelaide
The Alfred Hospital
Melbourne
Fiona Stanley Hospital
Murdoch, Murdoch, WA 6150
Macquirie University Hopsital
Ryde
Prince of Wales Hospital
Sydney, Sydney, NSW 2031
Princess Alexandra Hospital
Woolloongabba, Woolloongabba, QLD 4102,
Italy5 sites
Pineta Grande Hospital
Castel Volturno, Caserta, 81030
Policlinico San Donato
Milan, Milan, 20097
Centro Cardiologico Monzino
Milan
Ospedale San Raffaele - Cardiac
Milan
Azienda Ospedale Università Padova
Padova, Padua, 35128
Spain5 sites
Hospital General Universitario Dr. Balmis
Alicante
Hospital Clínic de Barcelona
Barcelona
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Clinico Universitario San Carlos
Madrid, Madrid, 28040
Hospital Virgen de Rocio
Seville
United Kingdom4 sites
Royal Victoria Hospital
Belfast
Leeds General Infirmary
Leeds
Kings College Hospital
London
Morriston Hospital
Swansea, Swansea, SA6 6NL
France3 sites
CHU Gabriel Montpied
Clermont-Ferrand
Hopital Haut Leveque
Pessac
Clinique Pasteur Toulouse
Toulouse
About this study
Official title: VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
Evaluation of TAVR using the NAVITOR valve in a Global Investigation.
Read the detailed description
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-valve application.
- Conditions
- Symptomatic Severe Aortic Stenosis
- Being tested
- Navitor Transcatheter Aortic valve and FlexNav Delivery system
- Keywords
- NAVITOR Heart disease, Transcatheter aortic valve implantation (TAVI), Aortic stenosis Cardiovascular disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navitor Transcatheter Aortic valve and FlexNav Delivery systemDevice
Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Primary Analysis Cohort | Experimental | Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+) Receives: Device: Navitor Transcatheter Aortic valve and FlexNav Delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL)
The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.
Measured: at 30 Days
Primary Safety Endpoint: The Rates of All-cause Mortality or Fatal Stroke/Stroke With Disability
The composite of rate of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure as adjudicated by the CEC per Valve Academic Research Consortium (VARC-3) definitions calculated against the performance goal of 11.3%.
Measured: at 12 months
Secondary outcomes (3)
Mean Change in Mean Transvalvular Gradient
This endpoint was evaluated by comparing the mean paired difference in mean transvalvular gradient from baseline to 12 months against the performance goal of -10mmHg.
Measured: Baseline to 12 months
Mean Change in Effective Orifice Area (EOA)
This endpoint was evaluated by comparing the mean paired difference in effective orifice area (EOA) from baseline to 12 months against the performance goal of 0.4 cm².
Measured: Baseline to12 months
Mean Change In KCCQ Quality Of Life Score
This endpoint was evaluated by comparing the mean paired difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) score from baseline to 12 months against the performance goal of 5 points. Higher KCCQ scores indicate better symptoms and physical functioning. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a tool of heart failure-specific health status questionnaire. Score ranges from 0 to 100, where 0 represents the worst and 100 represents the best quality of life. Higher scores indicate better quality of life and lower symptoms. The mean change from baseline reflects the average improvement (positive values) or worsening (negative values) in patient-reported health status.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start13 Jul 2021
- Primary completion2 Jan 2025
- Study completion28 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptomatic Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Worthley, M.D., Ph. D., Principal investigator, Macquarie University HospitalNicolas van Mieghem, M.D., Ph. D., Principal investigator, Erasmus Medical CenterBarathi Sethuraman, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788888
- Sponsor's protocol ID
- ABT-CIP-10342
- Acronym
- VANTAGE
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2021
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
- ClinicalTrials.gov ID
- NCT04788888
- Acronym / sponsor ID
- VANTAGE / ABT-CIP-10342
- Conditions
- Symptomatic Severe Aortic Stenosis
- Keywords
- NAVITOR Heart disease, Transcatheter aortic valve implantation (TAVI), Aortic stenosis Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 28 Feb 2036 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of TAVR using the NAVITOR valve in a Global Investigation.
Detailed description
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-valve application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Analysis Cohort | Experimental | Device: Navitor Transcatheter Aortic valve and FlexNav Delivery systemNavitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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). *
- 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 ≥ 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).
- 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.
Key exclusion criteria (19 listed)
- Life expectancy is less than 2 years in the opinion of the Investigator.
- 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.
- Untreated clinically significant coronary artery disease requiring revascularization.
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navitor Transcatheter Aortic valve and FlexNav Delivery systemNavitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk. Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system. | Device | Primary Analysis Cohort |
Primary outcome
Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL)
Time frame: at 30 Days
The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.
Primary Safety Endpoint: The Rates of All-cause Mortality or Fatal Stroke/Stroke With Disability
Time frame: at 12 months
The composite of rate of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure as adjudicated by the CEC per Valve Academic Research Consortium (VARC-3) definitions calculated against the performance goal of 11.3%.
3 secondary outcomes
Mean Change in Mean Transvalvular Gradient
Time frame: Baseline to 12 months
Mean Change in Effective Orifice Area (EOA)
Time frame: Baseline to12 months
Mean Change In KCCQ Quality Of Life Score
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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DurAVR™ THV EU-EFS
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ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
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Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Worthley, M.D., Ph. D. principal investigator
Macquarie University Hospital
Nicolas van Mieghem, M.D., Ph. D. principal investigator
Erasmus Medical Center
Barathi Sethuraman study director
Abbott
37 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navitor Transcatheter Aortic valve and FlexNav Delivery system in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 37 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, Australia, Italy, Spain, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL) (time frame: at 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.