Back to resultsEvolut PRO China Clinical Study
Primary Purpose
Severe, Symptomatic Aortic Stenosis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Medtronic CoreValve™ Evolut™ PRO System
Sponsored by
About this trial
This is an interventional treatment trial for Severe, Symptomatic Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beijing Anzhen Hospital, Capital Medical University
- Chinese PLA General Hospital, Chinese PLA Medical School
- West China Hospital of Sichuan University
- The Second Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medtronic CoreValve™ Evolut™ PRO System
Arm Description
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)
Outcomes
Primary Outcome Measures
All-cause mortality
Percentage of participants with all-cause mortality, cardiovascular and non-cardiovascular mortality
Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation
Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE)
Secondary Outcome Measures
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)
Event rates of the individual components of the VARC II composite
Event rate of the individual components listed in the outcome 3
New permanent pacemaker rate
New permanent pacemaker rate
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
Valve performance parameter - Mean aortic gradient
• Mean aortic gradient
Valve performance parameter - Effective orifice area
• Effective orifice area
Valve performance parameter -Degree of aortic regurgitation (transvalvular, paravalvular, total)
• Degree of aortic regurgitation (transvalvular, paravalvular, total)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04982588
Brief Title
Evolut PRO China Clinical Study
Official Title
Medtronic CoreValve™ Evolut™ PRO System China Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2021 (Actual)
Primary Completion Date
March 17, 2023 (Actual)
Study Completion Date
November 28, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe, Symptomatic Aortic Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medtronic CoreValve™ Evolut™ PRO System
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Medtronic CoreValve™ Evolut™ PRO System
Intervention Description
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)
Primary Outcome Measure Information:
Title
All-cause mortality
Description
Percentage of participants with all-cause mortality, cardiovascular and non-cardiovascular mortality
Time Frame
30 days
Title
Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation
Description
Percentage (%) of evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of an VARC II combined composite
Description
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)
Time Frame
30 days
Title
Event rates of the individual components of the VARC II composite
Description
Event rate of the individual components listed in the outcome 3
Time Frame
30 days
Title
New permanent pacemaker rate
Description
New permanent pacemaker rate
Time Frame
30 days
Title
Device success rate
Description
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
Time Frame
Between 24 hours and 7 days post procedure
Title
Valve performance parameter - Mean aortic gradient
Description
• Mean aortic gradient
Time Frame
30 days
Title
Valve performance parameter - Effective orifice area
Description
• Effective orifice area
Time Frame
30 days
Title
Valve performance parameter -Degree of aortic regurgitation (transvalvular, paravalvular, total)
Description
• Degree of aortic regurgitation (transvalvular, paravalvular, total)
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Event rates of TAVI-related complications
Description
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)
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
All-cause mortality
Description
Percentage of participants with all-cause mortality, cardiovascular and non-cardiovascular mortality
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
All stroke
Description
Incidence of stroke (disabling and non-disabling)
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
Myocardial infarction
Description
Incidence of periprocedural MI and spontaneous MI
Time Frame
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
Incidence of life-threatening bleeding
Description
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)
Time Frame
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
New AV-Conduction disturbances
Description
Incidence of left bundle branch block and Right bundle branch block
Time Frame
30 days
Title
Incidence of prosthetic valve endocarditis
Description
Incidence of prosthetic valve endocarditis:
Fulfillment of the following Duke criteria for definite endocarditis
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
Time Frame
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
Incidence of Prosthetic valve thrombosis
Description
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.
Time Frame
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
Incidence of valve-related dysfunction
Description
Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II)
Time Frame
1 year, 2 years, 3 years, 4 years and 5 years
Title
Incidence of Valve-related dysfunction requiring repeat procedure
Description
Incidence of Valve-related dysfunction requiring repeat procedure
Time Frame
30days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
Valve hemodynamic performance metric - Mean aortic gradient
Description
• Mean aortic gradient
Time Frame
1 year, 2 years, 3 years, 4 years and 5 years
Title
Valve hemodynamic performance metric - Effective orifice area
Description
• Effective orifice area
Time Frame
1 year, 2 years, 3 years, 4 years and 5 years
Title
Valve hemodynamic performance metric - Degree of aortic regurgitation (transvalvular, paravalvular, total)
Description
• Degree of aortic regurgitation (transvalvular, paravalvular, total)
Time Frame
1 year, 2 years, 3 years, 4 years and 5 years
Title
Incidence of New York Heart Association (NYHA) functional classification
Description
Incidence of New York Heart Association (NYHA) functional classification
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Title
Quality of Life change from baseline EuroQol-5 Dimension [EQ-5D]
Description
QoL: EQ-5D
Time Frame
30 days, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, MD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Chinese PLA General Hospital, Chinese PLA Medical School
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
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Evolut PRO China Clinical Study
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