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

Abbott

Status: Completed

Conditions: Symptomatic Degenerative Aortic Stenosis; Severe Aortic Stenosis

Treatments: Device: Portico™ Valve, Portico Delivery System(s) and Loading System(s); Device: Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03752866

SJM-CIP-CL1003491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,001 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,001 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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