Active — Not RecruitingNot Applicable

Evolut PRO China Clinical Study

China52 participantsStarted 2021-07-17

Plain-language 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).

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

All-cause Mortality

Timeframe: 30 days

Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE)

Timeframe: 30 days

Trial details

NCT IDNCT04982588

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-17

Results submitted2024-02-29

View on ClinicalTrials.gov More Severe, Symptomatic Aortic Stenosis trials