Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

Symptomatic Severe Aortic Stenosis Clinical Trial

— VANTAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788888
• Other study ID #: ABT-CIP-10342
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2021
• Est. completion date: February 28, 2036

Study information

• Verified date: January 2024
• Source: Abbott Medical Devices
• Contact: Nadia Bouhdi
• Phone: +32 479 94 10 37
• Email: nadia.bouhdi[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 590
• Est. completion date: February 28, 2036
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Severe Aortic Stenosis

Intervention

Device:
• Navitor Transcatheter Aortic Valve and FlexNav Delivery System
For traditional application, the Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk. For the valve-in-valve application, the Navitor valve is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve. Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system

Locations

Country	Name	City	State
Australia	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
Austria	Universitätsklinik Graz	Graz
Austria	Kepler Universitätsklinikum GmbH	Linz
Austria	AKH Wien	Vienna
Denmark	Rigshospitalet	Copenhagen
France	CHU Gabriel Montpied	Clermont-Ferrand
France	Hopital Haut Leveque	Pessac
France	Clinique Pasteur Toulouse	Toulouse
Germany	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	DHZ München	München
Italy	Pineta Grande Hospital	Castel Volturno	Caserta
Italy	Centro Cardiologico Monzino	Milan
Italy	Ospedale San Raffaele - Cardiac	Milan
Italy	Policlinico San Donato	Milan
Italy	Azienda Ospedale Università Padova	Padova	Padua
Netherlands	Erasmus MC - Thoraxcenter	Rotterdam
Spain	Hospital General Universitario Dr. Balmis	Alicante
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Clinico Universitario San Carlos	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Virgen de Rocio	Sevilla
Switzerland	HerzZentrum Hirslanden	Zürich
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Kings College Hospital	London
United Kingdom	Morriston Hospital	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Austria,  Denmark,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of a composite of all-cause mortality or fatal stroke/stroke with disability at 12 months (Primary Safety Endpoint)	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	12 months post index procedure
Primary	The proportion of subjects who have moderate or greater paravalvular leak at 30 days (Primary Effectiveness Endpoint)	Moderate or greater paravalvular leak at 30 days	30 days post index procedure
Secondary	Transvalvular gradient	Mean change in mean transvalvular gradient between baseline and 12 months	12 months post index procedure
Secondary	Effective orifice area	Mean change in effective orifice area between baseline and 12 months	12 months post index procedure
Secondary	KCCQ quality of life score	Mean change in KCCQ quality of life score between baseline and 12 months	12 months post index procedure