CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
NCT ID: NCT03752866
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1001 participants
INTERVENTIONAL
2018-10-25
2022-07-28
Brief Summary
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Detailed Description
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Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.
The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Portico™ Valve, Delivery System(s) and Loading System(s)
Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system will be included.
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.
Portico™ Valve, FlexNav Delivery and Loading System(s)
Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems will be included.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
2. Have any evidence of left ventricular or atrial thrombus
3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
4. Have a non-calcified aortic annulus
5. Have congenital bicuspid or unicuspid leaflet configuration
6. Are unable to tolerate antiplatelet/anticoagulant therapy
7. Are pregnant at the time of signing informed consent
8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
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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Helge Möllmann
Role: PRINCIPAL_INVESTIGATOR
St. Johannes Hospital, Dortmund, Germany
Vinny Podichetty
Role: STUDY_DIRECTOR
Abbott Structural Heart
Locations
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Heart Care Partners- Wesley Hospital
Woolloongabba, Queensland, Australia
AZ Middelheim
Antwerp, , Belgium
University Hospital Olomouc
Olomouc, , Czechia
Kliniken der Friedrich-Alexander-Universitat
Erlangen, Bavaria, Germany
Kerckhoff-Klinik gGmbH
Bad Nauheim, , Germany
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
Berlin, , Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, , Germany
St.-Johannes-Hospital
Dortmund, , Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, , Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, , Germany
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg, , Germany
Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV
Karlsruhe, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Charite Campus Virchow Klinikum
Mitte, , Germany
Policlinico di Monza
Monza, Lombardy, Italy
Ospedale San Raffaele
Milan, , Italy
Policlinico San Donato
San Donato Milanese, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, Masovian Voivodeship, Poland
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalonia, Spain
Hospital General Juan Ramon Jimenez
Huelva, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Kantonsspital Aarau
Aarau, , Switzerland
Royal Victoria Hospital
Belfast, Ireland, United Kingdom
James Cook University Hoospital
Middlesbrough, North East England, United Kingdom
Morriston Hospital - ABM University Health Board
Morriston, Swansea, United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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References
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Mollmann H, Linke A, Nombela-Franco L, Sluka M, Francisco Oteo Dominguez J, Montorfano M, Kim WK, Arnold M, Vasa-Nicotera M, Fichtlscherer S, Conradi L, Camuglia A, Bedogni F, Kohli K, Manoharan G. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry. Struct Heart. 2023 Nov 11;8(1):100226. doi: 10.1016/j.shj.2023.100226. eCollection 2024 Jan.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SJM-CIP-CL1003491
Identifier Type: -
Identifier Source: org_study_id
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