The CONFIDENCE Registry

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03752866

Collaborator

(none)

1,001

Enrollment

Locations

Arms

50.2

Anticipated Duration (Months)

35.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Degenerative Aortic Stenosis Severe Aortic Stenosis	Device: Portico™ Valve, Portico Delivery System(s) and Loading Systems(s) Device: Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1001 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence

Actual Study Start Date :

Oct 25, 2018

Actual Primary Completion Date :

Nov 2, 2021

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cardiovascular Mortality [30 days from the index procedure]

Other Outcome Measures

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 [30 days from the index procedure]
VARC-2 definition of conversion to open surgery: Conversion to open sternotomy during the TAVI procedure secondary to any procedure-related complications
Coronary obstruction [30 days from the index procedure]
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
Valve embolization [30 days from the index procedure]
As per VARC-2 criteria: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus
Transcatheter valve-in-valve deployment [30 days from the index procedure]
Permanent pacemaker insertion [30 days from the index procedure]
Delivery profile characteristics [At 30 days post index procedure]
Delivery profile characteristics assess access vessel diameter, sheath utilization and sheath size
Implant success [At 30 days post index procedure]
Implant success defined as: Absence of procedural mortality Correct positioning of a single Portico prosthetic heart valve into the proper anatomical location
Echocardiographic assessment of hemodynamic valve performance [At 30 days post index procedure]
Echocardiographic assessment of hemodynamic valve performance include: Mean gradient Effective orifice area Paravalvular leak (PVL)
Clinical improvement from baseline [At 30 days post index procedure]
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
All-cause mortality All-cause mortality All-cause mortality [At 30 days post index procedure]
All-cause mortality [At 12 months post index procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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:

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)

Contacts and Locations

Locations

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