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Evaluation of the NAVITOR valve for treating severe aortic stenosis

VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

NA · Abbott Medical Devices · NCT04788888

This study is testing a new heart valve called the Navitor to see if it can safely help people with severe aortic stenosis who are not at high risk for surgery.

Quick facts

PhaseNA
Study typeInterventional
Enrollment590 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAbbott Medical Devices (industry)
Drugs / interventionsradiation
Locations39 sites (Adelaide and 38 other locations)
Trial IDNCT04788888 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Navitor valve in patients suffering from severe symptomatic aortic stenosis who are at intermediate or low risk for surgical mortality. The trial involves a transcatheter aortic valve implantation (TAVI) approach, utilizing the FlexNav delivery system. It also assesses the valve's performance in a valve-in-valve application, providing insights into its efficacy in various clinical scenarios.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with symptomatic severe aortic stenosis who are deemed at intermediate or low risk for surgical intervention.

Not a fit: Patients who are at high risk for surgical mortality or have contraindications for transcatheter heart valve intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could offer a less invasive treatment option for patients with severe aortic stenosis, potentially improving their quality of life and outcomes.

How similar studies have performed: Other studies have shown success with similar transcatheter aortic valve implantation approaches, indicating a promising avenue for treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

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

Where this trial is running

Adelaide and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Symptomatic Severe Aortic Stenosis, NAVITOR Heart disease, Transcatheter aortic valve implantation, Aortic stenosis Cardiovascular disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.