The CONFIDENCE Registry

Severe Aortic Stenosis Clinical Trial

Official title:

CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03752866
• Other study ID #: SJM-CIP-CL1003491
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1001
• Est. completion date: December 30, 2022
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Aortic Stenosis
• Symptomatic Degenerative Aortic Stenosis

Intervention

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
• 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

Locations

Country	Name	City	State
Australia	Heart Care Partners- Wesley Hospital	Woolloongabba	Queensland
Belgium	AZ Middelheim	Antwerpen
Czechia	University Hospital Olomouc	Olomouc
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim
Germany	Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin
Germany	Universitätsmedizin Berlin - Charité Campus Mitte (CCM)	Berlin
Germany	Charite Campus Virchow Klinikum	Berlin-Mitte
Germany	St.-Johannes-Hospital	Dortmund
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Kliniken der Friedrich-Alexander-Universitat	Erlangen	Bavaria
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt
Germany	UKE Hamburg (Universitatsklinik Eppendorf)	Hamburg
Germany	Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV	Karlsruhe
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Italy	Ospedale San Raffaele	Milano
Italy	Policlinico di Monza	Monza	Lombardy
Italy	Policlinico San Donato	San Donato Milanese
Italy	Ospedale San Bortolo	Vicenza
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny	Warsaw	Mazovia
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona	Catalonia
Spain	Hospital General Juan Ramon Jimenez	Huelva
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Switzerland	Kantonsspital Aarau	Aarau
United Kingdom	Royal Victoria Hospital	Belfast	Ireland
United Kingdom	King's College Hospital	London
United Kingdom	James Cook University Hoospital	Middlesbrough	North East England
United Kingdom	Morriston Hospital - ABM University Health Board	Morriston	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Belgium,  Czechia,  Germany,  Italy,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Myocardial Infarction		30 days from the index procedure
Other	Stroke (including disabling and non-disabling)		30 days from the index procedure
Other	Bleeding (life-threatening, major, minor)		30 days from the index procedure
Other	Acute kidney injury		30 days from the index procedure
Other	Vascular access site and access-related complications (major and minor)		30 days from the index procedure
Other	Annular rupture		30 days from the index procedure
Other	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
Other	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
Other	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
Other	Transcatheter valve-in-valve deployment		30 days from the index procedure
Other	Permanent pacemaker insertion		30 days from the index procedure
Other	Delivery profile characteristics	Delivery profile characteristics assess access vessel diameter, sheath utilization and sheath size	At 30 days post index procedure
Other	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
Other	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
Other	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
Other	All-cause mortality All-cause mortality All-cause mortality		At 30 days post index procedure
Other	All-cause mortality		At 12 months post index procedure
Primary	Cardiovascular Mortality		30 days from the index procedure