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 range

65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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