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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chinese PLA General Hospital, Chinese PLA Medical School
Beijing, Beijing Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
All-cause Mortality
All-cause mortality at 30 days
Time frame: 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)
Time frame: 30 days
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)
Time frame: 30 days
Event Rates of the Individual Components of the VARC II Composite
Event rate of the individual components listed in the outcome
Time frame: 30 days
New Permanent Pacemaker Rate
New permanent pacemaker rate
Time frame: 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
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Time frame: Between 24 hours and 7 days post procedure
Valve Performance Parameter - Mean Aortic Gradient
Mean aortic gradient
Time frame: 30 days
Valve Performance Parameter - Effective Orifice Area
Effective orifice area
Time frame: 30 days
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)
Degree of aortic regurgitation (transvalvular, paravalvular, total)
Time frame: 30 days