Evolut PRO China Clinical Study

Severe, Symptomatic Aortic Stenosis Clinical Trial

Official title: Medtronic CoreValve™ Evolut™ PRO System China Clinical Study

Status Active, not recruiting

Clinical Trial Summary

Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).

Clinical Trial Description

This study is a prospective, single arm, multi-center, interventional, pre-market trial to obtain clinical data from Chinese implanting centers to support product registration of the Medtronic CoreValve™ Evolut™ PRO System (TAV, DCS and LS) with the National Medical Product Administration (NMPA) in China. Estimating 65 subjects with a maximum of up to 70 subjects in China with an attempted implant and followed the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6months, 1 year, and annually through 5 years. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe, Symptomatic Aortic Stenosis

• NCT number: NCT04982588
• Study type: Interventional
• Source: Medtronic Cardiovascular
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 17, 2021
• Completion date: November 28, 2028