The CONFIDENCE Registry
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
About this trial
This is an interventional treatment trial for Symptomatic Degenerative Aortic Stenosis focused on measuring Portico™ valve, Portico™ valve delivery system, Portico™ valve loading system, Transcatheter Aortic Valve Replacement, Aortic Stenosis, Heart Valve Prosthesis, TAVR, TAVR Registry, Transcatheter Aortic Valve Implant, TAVI, TAVI Registry, FlexNav delivery system, FlexNav loading system
Eligibility Criteria
Inclusion Criteria:
- Subjects who are >18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
- Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
Exclusion Criteria:
Candidates will be excluded if any of the following conditions are present:
- Have sepsis, including active endocarditis
- Have any evidence of left ventricular or atrial thrombus
- Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
- Have a non-calcified aortic annulus
- Have congenital bicuspid or unicuspid leaflet configuration
- Are unable to tolerate antiplatelet/anticoagulant therapy
- Are pregnant at the time of signing informed consent
- Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
Sites / Locations
- Heart Care Partners- Wesley Hospital
- AZ Middelheim
- University Hospital Olomouc
- Kliniken der Friedrich-Alexander-Universitat
- Kerckhoff-Klinik gGmbH
- Charite Campus Virchow Klinikum
- Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
- Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
- St.-Johannes-Hospital
- Herzzentrum Dresden GmbH Universitätsklinik
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
- UKE Hamburg (Universitatsklinik Eppendorf)
- Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Policlinico di Monza
- Ospedale San Raffaele
- Policlinico San Donato
- Ospedale San Bortolo
- Samodzielny Publiczny Centralny Szpital Kliniczny
- Hospital de la Santa Creu I Sant Pau
- Hospital General Juan Ramon Jimenez
- Hospital Clinico San Carlos
- Hospital Universitario Puerta de Hierro
- Kantonsspital Aarau
- Royal Victoria Hospital
- James Cook University Hoospital
- Morriston Hospital - ABM University Health Board
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Portico™ Valve, Delivery System(s) and Loading Systems(s)
Portico™ Valve, FlexNav Delivery and Loading System(s)
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems