Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

Not Applicable

Recruiting

• Conditions: Symptomatic Severe Aortic Stenosis
• Interventions: Device: Navitor Transcatheter Aortic Valve and FlexNav Delivery System

• Registration Number: NCT04788888
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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 Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-09
• Study Start: 2021-06-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2036-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 590

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Navitor Transcatheter Aortic Valve, FlexNav Delivery System	Navitor Transcatheter Aortic Valve and 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+)

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who have moderate or greater paravalvular leak at 30 days (Primary Effectiveness Endpoint)	30 days post index procedure	Moderate or greater paravalvular leak at 30 days
Incidence of a composite of all-cause mortality or fatal stroke/stroke with disability at 12 months (Primary Safety Endpoint)	12 months post index procedure	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

Secondary Outcome Measures

Name	Time	Method
Transvalvular gradient	12 months post index procedure	Mean change in mean transvalvular gradient between baseline and 12 months
Effective orifice area	12 months post index procedure	Mean change in effective orifice area between baseline and 12 months
KCCQ quality of life score	12 months post index procedure	Mean change in KCCQ quality of life score between baseline and 12 months

Trial Locations

Locations (39)

DHZ München; 🇩🇪 München, Germany

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Telaviv, Israel

St. Andrew's Hospital; 🇦🇺 Adelaide, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Australia

Fiona Stanley Hospital; 🇦🇺 Murdoch, Australia

Macquirie University Hopsital; 🇦🇺 Ryde, Australia

Prince of Wales Hospital; 🇦🇺 Sydney, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Australia

Universitätsklinik Graz; 🇦🇹 Graz, Austria

Kepler Universitätsklinikum GmbH; 🇦🇹 Linz, Austria

AKH Wien; 🇦🇹 Vienna, Austria

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

Clinique Pasteur Toulouse; 🇫🇷 Toulouse, France

Kerckhoff-Klinik GgmbH; 🇩🇪 Bad Nauheim, Germany

Universitätsmedizin Berlin - Charité Campus Mitte (CCM); 🇩🇪 Berlin, Germany

St. Johannes-Hospital; 🇩🇪 Dortmund, Germany

Herzzentrum Dresden; 🇩🇪 Dresden, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt; 🇩🇪 Frankfurt, Germany

UKE Hamburg (Universitatsklinik Eppendorf); 🇩🇪 Hamburg, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Universität Mainz (Johannes Gutenberg-Universität Mainz); 🇩🇪 Mainz, Germany

Pineta Grande Hospital; 🇮🇹 Castel Volturno, Caserta, Italy

Azienda Ospedale Università Padova; 🇮🇹 Padova, Padua, Italy

Policlinico San Donato; 🇮🇹 Milan, Italy

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy

Ospedale San Raffaele - Cardiac; 🇮🇹 Milan, Italy

Erasmus MC - Thoraxcenter; 🇳🇱 Rotterdam, Netherlands

Hospital General Universitario Dr. Balmis; 🇪🇸 Alicante, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital Virgen de Rocio; 🇪🇸 Sevilla, Spain

HerzZentrum Hirslanden; 🇨🇭 Zürich, Switzerland

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom

Morriston Hospital; 🇬🇧 Swansea, United Kingdom