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The CONFIDENCE Registry

Primary Purpose

Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Portico™ Valve, Portico Delivery System(s) and Loading Systems(s)
Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems

Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems

Outcomes

Primary Outcome Measures

Cardiovascular Mortality

Secondary Outcome Measures

Full Information

First Posted
November 15, 2018
Last Updated
January 14, 2022
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT03752866
Brief Title
The CONFIDENCE Registry
Official Title
CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1001 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Portico™ Valve, Delivery System(s) and Loading Systems(s)
Arm Type
Experimental
Arm Description
Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems
Arm Title
Portico™ Valve, FlexNav Delivery and Loading System(s)
Arm Type
Experimental
Arm Description
Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems
Intervention Type
Device
Intervention Name(s)
Portico™ Valve, Portico Delivery System(s) and Loading Systems(s)
Intervention Description
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system
Intervention Type
Device
Intervention Name(s)
Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)
Intervention Description
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems
Primary Outcome Measure Information:
Title
Cardiovascular Mortality
Time Frame
30 days from the index procedure
Other Pre-specified Outcome Measures:
Title
Myocardial Infarction
Time Frame
30 days from the index procedure
Title
Stroke (including disabling and non-disabling)
Time Frame
30 days from the index procedure
Title
Bleeding (life-threatening, major, minor)
Time Frame
30 days from the index procedure
Title
Acute kidney injury
Time Frame
30 days from the index procedure
Title
Vascular access site and access-related complications (major and minor)
Time Frame
30 days from the index procedure
Title
Annular rupture
Time Frame
30 days from the index procedure
Title
Conversion to open surgery
Description
VARC-2 definition of conversion to open surgery: Conversion to open sternotomy during the TAVI procedure secondary to any procedure-related complications
Time Frame
30 days from the index procedure
Title
Coronary obstruction
Description
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
Time Frame
30 days from the index procedure
Title
Valve embolization
Description
As per VARC-2 criteria: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus
Time Frame
30 days from the index procedure
Title
Transcatheter valve-in-valve deployment
Time Frame
30 days from the index procedure
Title
Permanent pacemaker insertion
Time Frame
30 days from the index procedure
Title
Delivery profile characteristics
Description
Delivery profile characteristics assess access vessel diameter, sheath utilization and sheath size
Time Frame
At 30 days post index procedure
Title
Implant success
Description
Implant success defined as: Absence of procedural mortality Correct positioning of a single Portico prosthetic heart valve into the proper anatomical location
Time Frame
At 30 days post index procedure
Title
Echocardiographic assessment of hemodynamic valve performance
Description
Echocardiographic assessment of hemodynamic valve performance include: Mean gradient Effective orifice area Paravalvular leak (PVL)
Time Frame
At 30 days post index procedure
Title
Clinical improvement from baseline
Description
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
Time Frame
At 30 days post index procedure
Title
All-cause mortality All-cause mortality All-cause mortality
Time Frame
At 30 days post index procedure
Title
All-cause mortality
Time Frame
At 12 months post index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helge Möllmann
Organizational Affiliation
St. Johannes Hospital, Dortmund, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Care Partners- Wesley Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
AZ Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Kliniken der Friedrich-Alexander-Universitat
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Kerckhoff-Klinik gGmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charite Campus Virchow Klinikum
City
Berlin-Mitte
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
St.-Johannes-Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Herzzentrum Dresden GmbH Universitätsklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
UKE Hamburg (Universitatsklinik Eppendorf)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Policlinico di Monza
City
Monza
State/Province
Lombardy
ZIP/Postal Code
20900
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Policlinico San Donato
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny
City
Warsaw
State/Province
Mazovia
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Hospital de la Santa Creu I Sant Pau
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital General Juan Ramon Jimenez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Royal Victoria Hospital
City
Belfast
State/Province
Ireland
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
James Cook University Hoospital
City
Middlesbrough
State/Province
North East England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Morriston Hospital - ABM University Health Board
City
Morriston
State/Province
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The CONFIDENCE Registry

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