The CONFIDENCE Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence

Conditions
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Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis

Intervention / Treatment
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* Device: Portico™ Valve, Portico Delivery System(s) and Loading Systems(s)
* Device: Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portico™ Valve, Delivery System(s) and Loading Systems(s)<br>Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems | Device: Portico™ Valve, Portico Delivery System(s) and Loading Systems(s)<br>* Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system<br>|
| Experimental: Portico™ Valve, FlexNav Delivery and Loading System(s)<br>Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems | Device: Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)<br>* Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Mortality |  | 30 days from the index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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