3D tech may sharpen heart valve placement in leaky aortic disease
NCT ID NCT07398911
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using 3D simulation before a minimally invasive aortic valve replacement helps doctors place the valve more accurately. It involves 354 adults aged 65 and older with severe aortic regurgitation (a leaky heart valve). Participants are randomly assigned to have the procedure with or without 3D simulation guidance, and researchers will compare how well the valve lines up in each group.
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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About 354 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * All of the following conditions must be met for inclusion: 1. Age ≥ 65 years; 2. Symptomatic severe native aortic regurgitation; 3. Aortic valve anatomy assessed by investigator as suitable for transcatheter aortic valve replacement ; 4. Subjects signed a written informed consent and agreed to cooperate with all follow-up examinations. Exclusion Criteria: * Patients meeting any of the following exclusion criteria were not included: 1. Active endocarditis; 2. Acute myocardial infarction or unstable angina pectoris, or severe coronary stenosis requiring coronary revascularization within 3 months; 3. Stroke or TIA (transient ischemic attack) within the past 3 months; 4. Any intracardiac mass, left ventricular or atrial thrombus, vegetation detected by echocardiography; 5. Severe obstructive hypertrophic cardiomyopathy (LVOTG peak ≥ 30 mmHg at rest); Note: Literature Basis: Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy 2023 6. History of bleeding tendency or coagulopathy or refusal of blood transfusion; 7. Active gastric ulcer or active gastrointestinal (GI) bleeding within 3 months; 8. Presence of contraindication to anticoagulation or antiplatelet; 9. Complicated with severe other valve diseases requiring concurrent surgical intervention; 10. Prior aortic valve graft (mechanical or bioprosthetic); 11. Severe left ventricular dysfunction, left ventricular ejection fraction \< 30%; 12. Hepatic encephalopathy or acute active hepatitis; 13. Renal dysfunction (eGFR \< 30ml/min calculated according to Cockcroft-Gault formula) and/or ongoing renal replacement therapy; 14. Patients with severe dementia and other poor compliance, unable to ensure the completion of the investigator; 15. Emergency surgery required for any reason; 16. Known hypersensitivity to contrast agents or nitinol memory alloys or porcine products; 17. Patients who are pregnant or plan to become pregnant, or are taking estrogen or estrogen-like drugs (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study); 18. Other patients considered unsuitable for this clinical study by the investigator;
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xijing Hospital
Xi’an, Shanxi, 710032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new valve fix a leaky heart without open surgery?
- Heart MRI could predict when valve patients need surgery
- 5,500 patients to test new heart valve devices in massive safety study
- Less invasive heart valve replacement may be better for seniors with small valves
- No X-Rays, no dye: new heart valve procedure could protect kidneys
- New heart valve procedure could offer safer alternative to Open-Heart surgery for seniors