CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.

NACompletedINTERVENTIONAL
Enrollment

1,001

Participants

Timeline

Start Date

October 25, 2018

Primary Completion Date

November 2, 2021

Study Completion Date

July 28, 2022

Conditions
Symptomatic Degenerative Aortic StenosisSevere Aortic Stenosis
Interventions
DEVICE

Portico™ Valve, Portico Delivery System(s) and Loading System(s)

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.

DEVICE

Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.

Trial Locations (28)

2020

AZ Middelheim, Antwerp

4102

Heart Care Partners- Wesley Hospital, Woolloongabba

5001

Kantonsspital Aarau, Aarau

10117

Universitätsmedizin Berlin - Charité Campus Mitte (CCM), Berlin

12203

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF), Berlin

13353

Charite Campus Virchow Klinikum, Mitte

20097

Policlinico San Donato, San Donato Milanese

20132

Ospedale San Raffaele, Milan

20246

UKE Hamburg (Universitatsklinik Eppendorf), Hamburg

20900

Policlinico di Monza, Monza

21005

Hospital General Juan Ramon Jimenez, Huelva

28040

Hospital Clinico San Carlos, Madrid

28222

Hospital Universitario Puerta de Hierro, Madrid

36100

Ospedale San Bortolo, Vicenza

44137

St.-Johannes-Hospital, Dortmund

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

60590

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt

61231

Kerckhoff-Klinik gGmbH, Bad Nauheim

76133

Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV, Karlsruhe

77900

University Hospital Olomouc, Olomouc

91054

Kliniken der Friedrich-Alexander-Universitat, Erlangen

01307

Herzzentrum Dresden GmbH Universitätsklinik, Dresden

02-097

Samodzielny Publiczny Centralny Szpital Kliniczny, Warsaw

08025

Hospital de la Santa Creu I Sant Pau, Barcelona

BT12 6BA

Royal Victoria Hospital, Belfast

TS4 3BW

James Cook University Hoospital, Middlesbrough

SA6 6NL

Morriston Hospital - ABM University Health Board, Morriston

SE5 9RS

King's College Hospital, London

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY