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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03752866
Study type Interventional
Source Abbott Medical Devices
Contact
Status Active, not recruiting
Phase N/A
Start date October 25, 2018
Completion date December 30, 2022

See also
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