New heart valve device offers hope for High-Risk patients
NCT ID NCT04982588
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new heart valve device, the Medtronic CoreValve Evolut PRO, in 52 Chinese patients with severe aortic stenosis who are at high risk for open-heart surgery. The device is inserted through a catheter, avoiding major surgery. Researchers are checking how safe and effective it is by measuring death rates and valve function at 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Medtronic CoreValve Evolut PRO heart valve device
- What this could lead to
- If successful, this could provide a safer, less invasive option for Chinese patients with severe aortic stenosis who are too high-risk for open-heart surgery.
- What could go wrong
- This is a small, early-stage study with only 52 participants, so results may not apply to everyone. Risks include bleeding, stroke, or kidney injury.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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52 people
The number who actually took part.
- Started
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Jul 2021
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
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Chinese PLA General Hospital, Chinese PLA Medical School
Beijing, Beijing Municipality, 100000, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610000, China
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