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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03752866




Registration number
NCT03752866
Ethics application status
Date submitted
15/11/2018
Date registered
26/11/2018
Date last updated
21/10/2024

Titles & IDs
Public title
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
Scientific title
CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
Secondary ID [1] 0 0
SJM-CIP-CL1003491
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Degenerative Aortic Stenosis 0 0
Severe Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Portico™ Valve, Portico Delivery System(s) and Loading System(s)
Treatment: Devices - Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)

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.

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.


Treatment: Devices: 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.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cardiovascular Mortality
Timepoint [1] 0 0
30 days from the index procedure
Secondary outcome [1] 0 0
Number of Subjects With Myocardial Infarction
Timepoint [1] 0 0
At 30 days
Secondary outcome [2] 0 0
Number of Subjects With Stroke
Timepoint [2] 0 0
At 30 days
Secondary outcome [3] 0 0
Number of Subjects With Bleeding Events
Timepoint [3] 0 0
At 30 days
Secondary outcome [4] 0 0
Number of Subjects With Acute Kidney Injury
Timepoint [4] 0 0
At 30 days
Secondary outcome [5] 0 0
Number of Subjects With Vascular Complications
Timepoint [5] 0 0
At 30 days
Secondary outcome [6] 0 0
Number of Subjects With Annular Rupture
Timepoint [6] 0 0
At 30 days
Secondary outcome [7] 0 0
Number of Subjects With Coronary Obstruction
Timepoint [7] 0 0
At 30 days
Secondary outcome [8] 0 0
Number of Subjects Undergoing Conversion To Open Surgery
Timepoint [8] 0 0
At 30 days
Secondary outcome [9] 0 0
Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment
Timepoint [9] 0 0
At 30 days
Secondary outcome [10] 0 0
Number Of Subjects With Valve Embolization
Timepoint [10] 0 0
At 30 days
Secondary outcome [11] 0 0
Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion
Timepoint [11] 0 0
At 30 days
Secondary outcome [12] 0 0
Vessel Diameter
Timepoint [12] 0 0
At 30 days
Secondary outcome [13] 0 0
Introducer Sheath Used
Timepoint [13] 0 0
At 30 days
Secondary outcome [14] 0 0
Implant Success
Timepoint [14] 0 0
At 30 days
Secondary outcome [15] 0 0
Effective Orifice Area
Timepoint [15] 0 0
At 30 days
Secondary outcome [16] 0 0
Aortic Valve Mean Gradient
Timepoint [16] 0 0
At 30 days
Secondary outcome [17] 0 0
Number of Subjects With Paravalvular Leak (PVL)
Timepoint [17] 0 0
At 30 days
Secondary outcome [18] 0 0
NYHA Classification
Timepoint [18] 0 0
At 30 days
Secondary outcome [19] 0 0
EQ5D-3L Visual Analog Scale Value
Timepoint [19] 0 0
At 30 days
Secondary outcome [20] 0 0
Kaplan-Meier Rate of All-cause Mortality
Timepoint [20] 0 0
At 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2022
Sample size
Target
Accrual to date
Final
1001
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Heart Care Partners- Wesley Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Czechia
State/province [2] 0 0
Olomouc
Country [3] 0 0
Germany
State/province [3] 0 0
Bavaria
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Nauheim
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin-Mitte
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Dortmund
Country [8] 0 0
Germany
State/province [8] 0 0
Dresden
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Germany
State/province [11] 0 0
Karlsruhe
Country [12] 0 0
Germany
State/province [12] 0 0
Mainz
Country [13] 0 0
Italy
State/province [13] 0 0
Lombardy
Country [14] 0 0
Italy
State/province [14] 0 0
Milano
Country [15] 0 0
Italy
State/province [15] 0 0
San Donato Milanese
Country [16] 0 0
Italy
State/province [16] 0 0
Vicenza
Country [17] 0 0
Poland
State/province [17] 0 0
Mazovia
Country [18] 0 0
Spain
State/province [18] 0 0
Catalonia
Country [19] 0 0
Spain
State/province [19] 0 0
Huelva
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Switzerland
State/province [21] 0 0
Aarau
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Ireland
Country [23] 0 0
United Kingdom
State/province [23] 0 0
North East England
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Swansea
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03752866
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helge Möllmann
Address 0 0
St. Johannes Hospital, Dortmund, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03752866