NCT03752866

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

CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,001 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Symptomatic Degenerative Aortic Stenosis
• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2018-10-25
• Primary completion: 2021-11-02
• Completion: 2022-07-28
• First posted: 2018-11-26
• Last updated: 2024-10-21
• Results posted: 2024-10-21

Locations

28 sites across 9 countries: Australia, Belgium, Czechia, Germany, Italy, Poland, Spain, Switzerland, United Kingdom