Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
NCT ID: NCT04788888
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
590 participants
INTERVENTIONAL
2021-06-13
2036-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Navitor Transcatheter Aortic Valve, 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+)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
100 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Worthley, M.D., Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Macquarie University Hospital
Nicolas van Mieghem, M.D., Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Barathi Sethuraman
Role: STUDY_DIRECTOR
Abbott
Locations
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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
DHZ München
München, , Germany
Shaare Zedek Medical Center
Jerusalem, Telaviv, Israel
Pineta Grande Hospital
Castel Volturno, Caserta, Italy
Azienda Ospedale Università Padova
Padua, 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
Seville, , Spain
HerzZentrum Hirslanden
Zurich, , Switzerland
Royal Victoria Hospital
Belfast, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Kings College Hospital
London, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Joseph Montarello
Role: primary
Gerald Yong
Role: primary
Stephen Worthley
Role: primary
Nigel Jepson
Role: primary
Anthony Camuglia
Role: primary
Clemens Steinwender
Role: primary
Martin Andreas
Role: primary
Souteyrand Géraud
Role: primary
Lionel Leroux
Role: primary
Didier Tchetche
Role: primary
Won-Keun Kim
Role: primary
Henryk Dreger
Role: primary
Helge Möllmann
Role: primary
Axel Linke
Role: primary
Philipp Seppelt
Role: primary
Lenard Conradi
Role: primary
Mohamed Abdel-Wahab
Role: primary
Hendrik Ruge
Role: primary
Danny Dvir, MD
Role: primary
Arturo Giordano
Role: primary
Giuseppe Tarantini
Role: primary
Francesco Bedogni
Role: primary
Federico De Marco
Role: primary
Francesco Maisano
Role: primary
Juan Ruiz-Nodar
Role: primary
Ander Regueiro
Role: primary
Jose Luis Zamorano
Role: primary
Luis Nombela
Role: primary
José Diaz
Role: primary
Ganesh Manoharan
Role: primary
Michael Cunnington
Role: primary
Phillip MacCarthy
Role: primary
Alexander Chase
Role: primary
Other Identifiers
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ABT-CIP-10342
Identifier Type: -
Identifier Source: org_study_id
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