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Evolut PRO China Clinical Study

NCT04982588 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-12-03

Study results available
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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).

Conditions

  • Severe, Symptomatic Aortic Stenosis

Interventions

DEVICE

Medtronic CoreValve™ Evolut™ PRO System

The system comprised of the following three components: 1. CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV) 2. EnVeo™ PRO Delivery Catheter System (DCS) 3. EnVeo™ PRO Loading System (LS)

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Jianan Wang, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-17
Primary Completion
2023-03-17
Completion
2028-05-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982588 on ClinicalTrials.gov