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

NCT03752866 | Completed Results

• 1 other identifier: SJM-CIP-CL1003491
• Study Type: interventional
• Target: 1,001
• Locations: 9 countries
• Sites: 28

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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

  At 30 days

• Number of Subjects With Vascular Complications

  At 30 days

Study Arms (2)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

Interventions

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

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.

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

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

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (28)

Heart Care Partners- Wesley Hospital

Woolloongabba, Queensland, 4102, Australia

Location

AZ Middelheim

Antwerp, 2020, Belgium

Location

University Hospital Olomouc

Olomouc, 77900, Czechia

Location

Kliniken der Friedrich-Alexander-Universitat

Erlangen, Bavaria, 91054, Germany

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, 61231, Germany

Location

Universitätsmedizin Berlin - Charité Campus Mitte (CCM)

Berlin, 10117, Germany

Location

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 12203, Germany

Location

St.-Johannes-Hospital

Dortmund, 44137, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, 01307, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt, 60590, Germany

Location

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, 20246, Germany

Location

Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV

Karlsruhe, 76133, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Charite Campus Virchow Klinikum

Mitte, 13353, Germany

Location

Policlinico di Monza

Monza, Lombardy, 20900, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Hospital General Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Royal Victoria Hospital

Belfast, Ireland, BT12 6BA, United Kingdom

Location

James Cook University Hoospital

Middlesbrough, North East England, TS4 3BW, United Kingdom

Location

Morriston Hospital - ABM University Health Board

Morriston, Swansea, SA6 6NL, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• Mollmann H, Linke A, Nombela-Franco L, Sluka M, Francisco Oteo Dominguez J, Montorfano M, Kim WK, Arnold M, Vasa-Nicotera M, Fichtlscherer S, Conradi L, Camuglia A, Bedogni F, Kohli K, Manoharan G. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry. Struct Heart. 2023 Nov 11;8(1):100226. doi: 10.1016/j.shj.2023.100226. eCollection 2024 Jan.

  PMID: 38283573 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Vinny Podichetty, Sr. Director, Global Clinical Affairs
• Organization: Abbott

vinny.podichetty@abbott.com

+1 408-845-1639

Study Officials

• Helge Möllmann

  St. Johannes Hospital, Dortmund, Germany

  PRINCIPAL INVESTIGATOR

• Vinny Podichetty

  Abbott Structural Heart

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 26, 2018
• Study Start: October 25, 2018
• Primary Completion: November 2, 2021
• Study Completion: July 28, 2022
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); BE (1); ES (4); PL (1); CH (1); AU (1); DE (11); CZ (1); GB (4)