Evolut PRO China Clinical Study

Medtronic CoreValve™ Evolut™ PRO System China Clinical Study

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Severe, Symptomatic Aortic Stenosis
• Intervention / Treatment: Device: Medtronic CoreValve™ Evolut™ PRO System

Detailed Description

The study is targeting 6 centers with a maximum of 8 centers in China and estimating 65 subjects with a maximum of up to 70 subjects with attempted implants including 50 subjects with an attempted implant in primary study population and the first two attempted subjects at each site for roll-in population. The subjects will follow the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6 months, 1 year, and annually through 5 years.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Beijing AnZhen Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100000
      • Chinese PLA General Hospital, Chinese PLA Medical School
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. 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
3. Symptoms of aortic stenosis and NYHA ≥ II

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medtronic CoreValve™ Evolut™ PRO System; The system comprised of the following three components: CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV); EnVeo™ PRO Delivery Catheter System (DCS); EnVeo™ PRO Loading System (LS)	Device: Medtronic CoreValve™ Evolut™ PRO System; The system comprised of the following three components: CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV); EnVeo™ PRO Delivery Catheter System (DCS); EnVeo™ PRO Loading System (LS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of an VARC II Combined Composite	Incidence of an VARC II combined composite includes the following components: All-cause mortality; All stroke (disabling and non-disabling); Life-threatening bleeding; Acute kidney injury: stage 2 or 3 (including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complication; Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)	30 days
Event Rates of the Individual Components of the VARC II Composite	Event rate of the individual components listed in the outcome	30 days
New Permanent Pacemaker Rate	New permanent pacemaker rate	30 days
Device Success Rate	Device success rate: Percentage of participants with absence of procedural mortality, AND; Percentage of participants with correct positioning of a single prosthetic heart valve into the proper anatomical location, AND; Percentage of participants with intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3m/sec), AND absence of moderate or severe prosthetic valve regurgitation	Between 24 hours and 7 days post procedure
Valve Performance Parameter - Mean Aortic Gradient	Mean aortic gradient	30 days
Valve Performance Parameter - Effective Orifice Area	Effective orifice area	30 days
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)	Degree of aortic regurgitation (transvalvular, paravalvular, total)	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Rates of TAVI-related Complications	Rate of the following TAVI-related complications: change to surgery; need for cardiopulmonary mechanical assistance; coronary occlusion or obstruction; annular rupture or dissection; ventricular perforation; mitral valve damage; prosthetic valve displacement, migration, or embolism; acute kidney injury (up to 7 days post procedure)	30 days
Myocardial Infarction	Incidence of MI	30 days
Incidence of Life-threatening Bleeding	Incidence of life-threatening bleeding: Fatal bleeding (BARC type 5) OR; Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR; Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR; Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)	30 days
New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB))	Incidence of either LBBB or RBBB	30 days
Incidence of Prosthetic Valve Thrombosis	Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.	30 days
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	Incidence of Valve-related dysfunction requiring repeat procedure	30 days
All-cause Mortality	Percentage of participants with all-cause mortality	6 months
All-cause Mortality	Percentage of participants with all-cause mortality	1 year
All Stroke	Incidence of stroke (disabling and non-disabling)	6 months
All Stroke	Incidence of stroke (disabling and non-disabling)	1 year
Myocardial Infarction	Incidence of MI	6 months
Myocardial Infarction	Incidence of MI	1 Year
Incidence of Life-threatening Bleeding	Incidence of life-threatening bleeding: Fatal bleeding (BARC type 5) OR; Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR; Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR; Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)	6 months
Incidence of Life-threatening Bleeding	Incidence of life-threatening bleeding: Fatal bleeding (BARC type 5) OR; Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR; Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR; Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)	1 Year
Incidence of Prosthetic Valve Thrombosis	Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.	6 months
Incidence of Prosthetic Valve Thrombosis	Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.	1 Year
Valve-related Dysfunction	Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II)	1 Year
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	Incidence of Valve-related dysfunction requiring repeat procedure	6 months
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	Incidence of Valve-related dysfunction requiring repeat procedure	1 Year
Valve Hemodynamic Performance Metric - Mean Aortic Gradient	Mean aortic gradient	1 year
Valve Hemodynamic Performance Metric - Effective Orifice Area	Effective orifice area	1 year
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)	Degree of aortic regurgitation (transvalvular, paravalvular, total)	1 year
New York Heart Association (NYHA) Functional Classification	New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.	30 days
New York Heart Association (NYHA) Functional Classification	New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.	6 month
New York Heart Association (NYHA) Functional Classification	New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.	1 Year
Incidence of Prosthetic Valve Endocarditis	Incidence of prosthetic valve endocarditis: Any one of the following: Fulfillment of the following Duke criteria for definite endocarditisHistologic and/or microbiologic evidence of infection at surgery or autopsy, or2 major criteria, or1 major criteria and 3 minor criteria, or5 minor criteria; Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation; Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy	30 days
Incidence of Prosthetic Valve Endocarditis	Incidence of prosthetic valve endocarditis: Any one of the following: Fulfillment of the following Duke criteria for definite endocarditisHistologic and/or microbiologic evidence of infection at surgery or autopsy, or2 major criteria, or1 major criteria and 3 minor criteria, or5 minor criteria; Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation; Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy	6 months
Incidence of Prosthetic Valve Endocarditis	Incidence of prosthetic valve endocarditis: Any one of the following: Fulfillment of the following Duke criteria for definite endocarditisHistologic and/or microbiologic evidence of infection at surgery or autopsy, or2 major criteria, or1 major criteria and 3 minor criteria, or5 minor criteria; Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation; Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy	1 Year
EQ-5D Quality of Life	EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).	30 days
EQ-5D Quality of Life	EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).	1 Year
All-cause Mortality	Percentage of participants with all-cause mortality	2 year
All Stroke	Incidence of stroke (disabling and non-disabling)	2 year
Myocardial Infarction	Incidence of MI	2 Year
Incidence of Life-threatening Bleeding	Incidence of life-threatening bleeding: Fatal bleeding (BARC type 5) OR; Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR; Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR; Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)	2 Year
Incidence of Prosthetic Valve Endocarditis	Incidence of prosthetic valve endocarditis: Any one of the following: Fulfillment of the following Duke criteria for definite endocarditisHistologic and/or microbiologic evidence of infection at surgery or autopsy, or2 major criteria, or1 major criteria and 3 minor criteria, or5 minor criteria; Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation; Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy	2 Year
Incidence of Prosthetic Valve Thrombosis	Incidence of Prosthetic valve thrombosis: Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. *Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.	2 Year
Valve-related Dysfunction	Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II)	2 Year
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	Incidence of Valve-related dysfunction requiring repeat procedure	2 Year
Valve Hemodynamic Performance Metric - Mean Aortic Gradient	Mean aortic gradient	2 year
Valve Hemodynamic Performance Metric - Effective Orifice Area	Effective orifice area	2 year
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)	Degree of aortic regurgitation (transvalvular, paravalvular, total)	2 year
New York Heart Association (NYHA) Functional Classification	New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest). Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.	2 Year

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Jianan Wang, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2021
• Primary Completion (Actual): March 17, 2023
• Study Completion (Estimated): May 15, 2028

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: MDT18065EVR009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No