Clinical trial NCT04788888: Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
Official title: VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symptomatic Severe Aortic Stenosis
Keywords: NAVITOR Heart disease
Transcatheter aortic valve implantation (TAVI)
Aortic stenosis Cardiovascular disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-03-09
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of a composite of all-cause mortality or fatal stroke/stroke with disability at 12 months (Primary Safety Endpoint)
timeFrame: 12 months post index procedure
measure: The proportion of subjects who have moderate or greater paravalvular leak at 30 days (Primary Effectiveness Endpoint)
timeFrame: 30 days post index procedure
Secondary outcomes:
measure: Transvalvular gradient
timeFrame: 12 months post index procedure
measure: Effective orifice area
timeFrame: 12 months post index procedure
measure: KCCQ quality of life score
timeFrame: 12 months post index procedure
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: St. Andrew's Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Ryde
country: Australia
facility: Macquirie University Hopsital
city: Sydney
country: Australia
facility: Prince of Wales Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Graz
country: Austria
facility: Universitätsklinik Graz
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
city: Vienna
country: Austria
facility: AKH Wien
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GgmbH
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
city: Dortmund
country: Germany
facility: St. Johannes-Hospital
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
city: Hamburg
country: Germany
facility: UKE Hamburg (Universitatsklinik Eppendorf)
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Mainz
country: Germany
facility: Universität Mainz (Johannes Gutenberg-Universität Mainz)
city: München
country: Germany
facility: DHZ München
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Telaviv
city: Castel Volturno
country: Italy
facility: Pineta Grande Hospital
state: Caserta
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
state: Padua
city: Milan
country: Italy
facility: Policlinico San Donato
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Milan
country: Italy
facility: Ospedale San Raffaele - Cardiac
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thoraxcenter
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Sevilla
country: Spain
facility: Hospital Virgen de Rocio
city: Zürich
country: Switzerland
facility: HerzZentrum Hirslanden
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: Kings College Hospital
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Macquarie University Hospital
name: Stephen Worthley, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Nicolas van Mieghem, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott
name: Barathi Sethuraman
role: STUDY_DIRECTOR
References: