NCT04982588

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jul 2021May 2028

First Submitted

Initial submission to the registry

July 8, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

July 17, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 29, 2024

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2028

Expected
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

July 8, 2021

Results QC Date

February 29, 2024

Last Update Submit

November 17, 2025

Conditions

Severe, Symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

  • All-cause Mortality

    All-cause mortality at 30 days

    30 days

  • Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE)

    Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE)

    30 days

Secondary Outcomes (7)

  • Incidence of an VARC II Combined Composite

    30 days

  • Event Rates of the Individual Components of the VARC II Composite

    30 days

  • New Permanent Pacemaker Rate

    30 days

  • Device Success Rate

    Between 24 hours and 7 days post procedure

  • Valve Performance Parameter - Mean Aortic Gradient

    30 days

  • +2 more secondary outcomes

Other Outcomes (42)

  • Event Rates of TAVI-related Complications

    30 days

  • All-cause Mortality

    6 months

  • All-cause Mortality

    1 year

  • +39 more other outcomes

Study Arms (1)

Medtronic CoreValve™ Evolut™ PRO System

EXPERIMENTAL

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)

Device: Medtronic CoreValve™ Evolut™ PRO System

Interventions

Medtronic CoreValve™ Evolut™ PRO SystemDEVICE

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)

Medtronic CoreValve™ Evolut™ PRO System

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aortic valve area (AVA) \< 1.0 cm2 (or indexed AVA \<0.6 cm2/m2) OR mean gradient \> 40 mmHg, OR max aortic velocity \> 4.0 m/sec
  • High risk for SAVR defined as STS-PROM score ≥ 8% AND ≤ 15%, OR documented Heart Team agreement of high risk for AVR due to frailty or comorbidities
  • Symptoms of aortic stenosis and NYHA ≥ II

You may not qualify if:

  • Age is less than 65 years old
  • Non-calcified aortic valve
  • Bicuspid aortic valve with no raphe or 2 raphes (Sievers classification type 0 or type 2)
  • Ascending aortic diameter \> 4.5 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Chinese PLA General Hospital, Chinese PLA Medical School

Beijing, Beijing Municipality, 100000, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Results Point of Contact

Title
Fairy Liu
Organization
Medtronic, Inc.
rs.evolutprochinaclinicalstudy@medtronic.com
+86-02120325765

Study Officials

  • Jianan Wang, MD

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 29, 2021

Study Start

July 17, 2021

Primary Completion

March 17, 2023

Study Completion (Estimated)

May 15, 2028

Last Updated

December 3, 2025

Results First Posted

November 29, 2024

Record last verified: 2025-11

Locations

CN(4)