The CONFIDENCE Registry

CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Aortic Stenosis; Symptomatic Degenerative Aortic Stenosis
• Intervention / Treatment: Device: Portico™ Valve, Portico Delivery System(s) and Loading Systems(s); Device: Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)

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.

• Study Type: Interventional
• Enrollment (Actual): 1001
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Heart Care Partners- Wesley Hospital
• Belgium
  • Antwerpen, Belgium, 2020
    • AZ Middelheim
• Czechia
  • Olomouc, Czechia, 77900
    • University Hospital Olomouc
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik gGmbH
  • Berlin, Germany, 10117
    • Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
  • Berlin, Germany, 12203
    • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
  • Berlin-Mitte, Germany, 13353
    • Charite Campus Virchow Klinikum
  • Dortmund, Germany, 44137
    • St.-Johannes-Hospital
  • Dresden, Germany, 01307
    • Herzzentrum Dresden GmbH Universitätsklinik
  • Frankfurt, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Hamburg, Germany, 20246
    • UKE Hamburg (Universitatsklinik Eppendorf)
  • Karlsruhe, Germany, 76133
    • Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Kliniken der Friedrich-Alexander-Universitat
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele
  • San Donato Milanese, Italy, 20097
    • Policlínico San Donato
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo
  • Lombardy
    • Monza, Lombardy, Italy, 20900
      • Policlinico di Monza
• Poland
  • Mazovia
    • Warsaw, Mazovia, Poland, 02-097
      • Samodzielny Publiczny Centralny Szpital Kliniczny
• Spain
  • Huelva, Spain, 21005
    • Hospital General Juan Ramon Jimenez
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Hospital de la Santa Creu i Sant Pau
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • Ireland
    • Belfast, Ireland, United Kingdom, BT12 6BA
      • Royal Victoria Hospital
  • North East England
    • Middlesbrough, North East England, United Kingdom, TS4 3BW
      • James Cook University Hoospital
  • Swansea
    • Morriston, Swansea, United Kingdom, SA6 6NL
      • Morriston Hospital - ABM University Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Portico™ Valve, Delivery System(s) and Loading Systems(s); Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems	Device: Portico™ Valve, Portico Delivery System(s) and Loading Systems(s); Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system
EXPERIMENTAL: Portico™ Valve, FlexNav Delivery and Loading System(s); Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems	Device: Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s); Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular Mortality	30 days from the index procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial Infarction		30 days from the index procedure
Stroke (including disabling and non-disabling)		30 days from the index procedure
Bleeding (life-threatening, major, minor)		30 days from the index procedure
Acute kidney injury		30 days from the index procedure
Vascular access site and access-related complications (major and minor)		30 days from the index procedure
Annular rupture		30 days from the index procedure
Conversion to open surgery	VARC-2 definition of conversion to open surgery: Conversion to open sternotomy during the TAVI procedure secondary to any procedure-related complications	30 days from the index procedure
Coronary obstruction	As per VARC-2 criteria: Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure	30 days from the index procedure
Valve embolization	As per VARC-2 criteria: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus	30 days from the index procedure
Transcatheter valve-in-valve deployment		30 days from the index procedure
Permanent pacemaker insertion		30 days from the index procedure
Delivery profile characteristics	Delivery profile characteristics assess access vessel diameter, sheath utilization and sheath size	At 30 days post index procedure
Implant success	Implant success defined as: Absence of procedural mortality; Correct positioning of a single Portico prosthetic heart valve into the proper anatomical location	At 30 days post index procedure
Echocardiographic assessment of hemodynamic valve performance	Echocardiographic assessment of hemodynamic valve performance include: Mean gradient; Effective orifice area; Paravalvular leak (PVL)	At 30 days post index procedure
Clinical improvement from baseline	Clinical improvement from baseline assessed by: New York Heart Association (NYHA) functional class change from Baseline to 30 days; Quality of Life (QoL) questionnaire (EQ5D-3L) changes from baseline to 30 days	At 30 days post index procedure
All-cause mortality All-cause mortality All-cause mortality		At 30 days post index procedure
All-cause mortality		At 12 months post index procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Helge Möllmann, St. Johannes Hospital, Dortmund, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2018
• Primary Completion (ACTUAL): November 2, 2021
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 23, 2018
• First Posted (ACTUAL): November 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Transcatheter Aortic Valve Replacement; TAVI; TAVR; Transcatheter Aortic Valve Implant; Heart Valve Prosthesis; Portico™ valve; Portico™ valve delivery system; Portico™ valve loading system; TAVR Registry; TAVI Registry; FlexNav delivery system; FlexNav loading system
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: SJM-CIP-CL1003491

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No