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

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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). \*

• New York Heart Association (NYHA) Functional Classification of II, III, or IV \*

• 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). \*

• 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.

Locations
Other Locations
Australia
St. Andrew's Hospital
RECRUITING
Adelaide
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Macquirie University Hopsital
RECRUITING
Ryde
Prince of Wales Hospital
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Universitätsklinik Graz
WITHDRAWN
Graz
Kepler Universitätsklinikum GmbH
RECRUITING
Linz
AKH Wien
RECRUITING
Vienna
Denmark
Rigshospitalet
RECRUITING
Copenhagen
France
CHU Gabriel Montpied
RECRUITING
Clermont-ferrand
Hopital Haut Leveque
RECRUITING
Pessac
Clinique Pasteur Toulouse
RECRUITING
Toulouse
Germany
Kerckhoff-Klinik GgmbH
RECRUITING
Bad Nauheim
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
RECRUITING
Berlin
St. Johannes-Hospital
RECRUITING
Dortmund
Herzzentrum Dresden
RECRUITING
Dresden
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
RECRUITING
Frankfurt
UKE Hamburg (Universitatsklinik Eppendorf)
RECRUITING
Hamburg
Herzzentrum Leipzig GmbH
RECRUITING
Leipzig
Universität Mainz (Johannes Gutenberg-Universität Mainz)
WITHDRAWN
Mainz
DHZ München
RECRUITING
München
Israel
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Italy
Pineta Grande Hospital
RECRUITING
Castel Volturno
Centro Cardiologico Monzino
RECRUITING
Milan
Ospedale San Raffaele - Cardiac
RECRUITING
Milan
Policlinico San Donato
RECRUITING
Milan
Azienda Ospedale Università Padova
RECRUITING
Padua
Netherlands
Erasmus MC - Thoraxcenter
ACTIVE_NOT_RECRUITING
Rotterdam
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Clinico Universitario San Carlos
RECRUITING
Madrid
Hospital Ramón y Cajal
RECRUITING
Madrid
Hospital Virgen de Rocio
RECRUITING
Seville
Switzerland
HerzZentrum Hirslanden
ACTIVE_NOT_RECRUITING
Zurich
United Kingdom
Royal Victoria Hospital
RECRUITING
Belfast
Leeds General Infirmary
RECRUITING
Leeds
Kings College Hospital
RECRUITING
London
Morriston Hospital
RECRUITING
Swansea
Contact Information
Primary
Kim Behning
kimberly.behning@abbott.com
+16517565622
Backup
Li Lihua
lihua.li1@abbott.com
+1 612-413-0527
Time Frame
Start Date: 2021-06-13
Estimated Completion Date: 2036-02-28
Participants
Target number of participants: 590
Treatments
Experimental: 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+)
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov

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