Medtronic CoreValve™ Evolut™ PRO System: 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)
Study 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).
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
All-cause Mortality — 30 days All-cause mortality at 30 days
Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE) — 30 days Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE)
Trial sites (4)
Facility
City
Region
Status
Beijing Anzhen Hospital, Capital Medical University
Beijing
Beijing Municipality
Chinese PLA General Hospital, Chinese PLA Medical School
Beijing
Beijing Municipality
West China Hospital of Sichuan University
Chengdu
Sichuan
The Second Affiliated Hospital Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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