CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.

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: Completed
• Conditions: Severe Aortic Stenosis; Symptomatic Degenerative Aortic Stenosis
• Intervention / Treatment: Device: Portico™ Valve, Portico Delivery System(s) and Loading System(s); Device: Portico™ Valve, FlexNav Delivery System(s) and Loading System(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
    • Policlinico 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Mortality	Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.	30 days from the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Myocardial Infarction		At 30 days
Number of Subjects With Stroke		At 30 days
Number of Subjects With Bleeding Events		At 30 days
Number of Subjects With Acute Kidney Injury	The increase in creatinine must occur within 48 hours. Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output <0.5 mL/kg per hour for >6 but <12 hours. Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output <0.5 mL/kg per hour for >12 but <24 hours. Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.	At 30 days
Number of Subjects With Vascular Complications		At 30 days
Number of Subjects With Annular Rupture		At 30 days
Number of Subjects With Coronary Obstruction		At 30 days
Number of Subjects Undergoing Conversion To Open Surgery		At 30 days
Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment		At 30 days
Number Of Subjects With Valve Embolization		At 30 days
Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion		At 30 days
Vessel Diameter		At 30 days
Introducer Sheath Used	This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).	At 30 days
Implant Success		At 30 days
Effective Orifice Area	Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.	At 30 days
Aortic Valve Mean Gradient	Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.	At 30 days
Number of Subjects With Paravalvular Leak (PVL)		At 30 days
NYHA Classification	NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV).	At 30 days
EQ5D-3L Visual Analog Scale Value	The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state."	At 30 days
Kaplan-Meier Rate of All-cause Mortality	Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.	At 12 months

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 Director: Vinny Podichetty, Abbott Structural Heart

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): July 28, 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): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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