Clinical trial NCT04982588: Evolut PRO China Clinical Study
Official title: Medtronic CoreValve™ Evolut™ PRO System China Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Severe, Symptomatic Aortic Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause Mortality
timeFrame: 30 days
measure: Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE)
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of an VARC II Combined Composite
timeFrame: 30 days
measure: Event Rates of the Individual Components of the VARC II Composite
timeFrame: 30 days
measure: New Permanent Pacemaker Rate
timeFrame: 30 days
measure: Device Success Rate
timeFrame: Between 24 hours and 7 days post procedure
measure: Valve Performance Parameter - Mean Aortic Gradient
timeFrame: 30 days
measure: Valve Performance Parameter - Effective Orifice Area
timeFrame: 30 days
measure: Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)
timeFrame: 30 days
Other outcomes:
measure: Event Rates of TAVI-related Complications
timeFrame: 30 days
measure: All-cause Mortality
timeFrame: 6 months
measure: All-cause Mortality
timeFrame: 1 year
measure: All Stroke
timeFrame: 6 months
measure: All Stroke
timeFrame: 1 year
measure: Myocardial Infarction
timeFrame: 30 days
measure: Myocardial Infarction
timeFrame: 6 months
measure: Myocardial Infarction
timeFrame: 1 Year
measure: Incidence of Life-threatening Bleeding
timeFrame: 30 days
measure: Incidence of Life-threatening Bleeding
timeFrame: 6 months
measure: Incidence of Life-threatening Bleeding
timeFrame: 1 Year
measure: New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB))
timeFrame: 30 days
measure: Incidence of Prosthetic Valve Endocarditis
timeFrame: 30 days
measure: Incidence of Prosthetic Valve Endocarditis
timeFrame: 6 months
measure: Incidence of Prosthetic Valve Endocarditis
timeFrame: 1 Year
measure: Incidence of Prosthetic Valve Thrombosis
timeFrame: 30 days
measure: Incidence of Prosthetic Valve Thrombosis
timeFrame: 6 months
measure: Incidence of Prosthetic Valve Thrombosis
timeFrame: 1 Year
measure: Valve-related Dysfunction
timeFrame: 1 Year
measure: Incidence of Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: 30 days
measure: Incidence of Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: 6 months
measure: Incidence of Valve-related Dysfunction Requiring Repeat Procedure
timeFrame: 1 Year
measure: Valve Hemodynamic Performance Metric - Mean Aortic Gradient
timeFrame: 1 year
measure: Valve Hemodynamic Performance Metric - Effective Orifice Area
timeFrame: 1 year
measure: Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)
timeFrame: 1 year
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: 30 days
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: 6 month
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: 1 Year
measure: EQ-5Q Quality of Life
timeFrame: 30 days
measure: EQ-5Q Quality of Life
timeFrame: 1 Year
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital, Chinese PLA Medical School
state: Beijing
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: