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).

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.

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