Clinical trial NCT03752866: CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
Official title: CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Degenerative Aortic Stenosis
Severe Aortic Stenosis
Keywords: 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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-11-26
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.

Detailed description: The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.

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.

Eligibility criteria: Inclusion Criteria:

1. 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
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:

1. Have sepsis, including active endocarditis
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)

Primary outcomes:
measure: Cardiovascular Mortality
timeFrame: 30 days from the index procedure
Secondary outcomes:
measure: Number of Subjects With Myocardial Infarction
timeFrame: At 30 days
measure: Number of Subjects With Stroke
timeFrame: At 30 days
measure: Number of Subjects With Bleeding Events
timeFrame: At 30 days
measure: Number of Subjects With Acute Kidney Injury
timeFrame: At 30 days
measure: Number of Subjects With Vascular Complications
timeFrame: At 30 days
measure: Number of Subjects With Annular Rupture
timeFrame: At 30 days
measure: Number of Subjects With Coronary Obstruction
timeFrame: At 30 days
measure: Number of Subjects Undergoing Conversion To Open Surgery
timeFrame: At 30 days
measure: Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment
timeFrame: At 30 days
measure: Number Of Subjects With Valve Embolization
timeFrame: At 30 days
measure: Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion
timeFrame: At 30 days
measure: Vessel Diameter
timeFrame: At 30 days
measure: Introducer Sheath Used
timeFrame: At 30 days
measure: Implant Success
timeFrame: At 30 days
measure: Effective Orifice Area
timeFrame: At 30 days
measure: Aortic Valve Mean Gradient
timeFrame: At 30 days
measure: Number of Subjects With Paravalvular Leak (PVL)
timeFrame: At 30 days
measure: NYHA Classification
timeFrame: At 30 days
measure: EQ5D-3L Visual Analog Scale Value
timeFrame: At 30 days
measure: Kaplan-Meier Rate of All-cause Mortality
timeFrame: At 12 months
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Heart Care Partners- Wesley Hospital
state: Queensland
city: Antwerpen
country: Belgium
facility: AZ Middelheim
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Erlangen
country: Germany
facility: Kliniken der Friedrich-Alexander-Universitat
state: Bavaria
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin-Mitte
country: Germany
facility: Charite Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
city: Hamburg
country: Germany
facility: UKE Hamburg (Universitatsklinik Eppendorf)
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Monza
country: Italy
facility: Policlinico di Monza
state: Lombardy
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
state: Mazovia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
state: Catalonia
city: Huelva
country: Spain
facility: Hospital General Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
state: Ireland
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hoospital
state: North East England
city: Morriston
country: United Kingdom
facility: Morriston Hospital - ABM University Health Board
state: Swansea
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: St. Johannes Hospital, Dortmund, Germany
name: Helge Möllmann
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Structural Heart
name: Vinny Podichetty
role: STUDY_DIRECTOR
References: