Could ultrasound replace X-Rays in heart valve surgery?
NCT ID NCT07317804
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using only ultrasound (echocardiography) to guide a minimally invasive heart valve replacement is as effective as the standard method that combines X-ray and ultrasound. The goal is to reduce kidney injury from contrast dye and lower radiation exposure. About 212 patients aged 70+ with severe aortic stenosis will be randomly assigned to one of the two guidance methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Echocardiographic guidance (ultrasound) vs fluoroscopic guidance (X-ray) during TAVR procedure
- What this could lead to
- If successful, echo-only guidance could become a safer alternative for TAVR, reducing kidney damage and radiation exposure for patients.
- What could go wrong
- This is a Phase 4 trial with 212 participants, so results may not apply to all patients. Echo-only guidance may be less precise in some cases, potentially affecting valve placement.
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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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 212 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Patients aged 70 years or older with obvious clinical symptoms or a left ventricular ejection fraction less than 50% due to severe aortic valve stenosis (aortic valve orifice area \< 1.0 cm² or peak velocity ≥ 4.0 m/s or mean transvalvular pressure ≥ 40 mmHg); or patients with obvious clinical symptoms of low blood flow and low pressure difference aortic valve stenosis (effective aortic valve orifice area \< 1.0 cm², mean transvalvular pressure difference \< 40 mmHg, left ventricular ejection fraction \< 50%, stroke volume index \< 35 ml/m², and diagnosed as true severe aortic valve stenosis by dobutamine stress test); * 2\. Patients aged 65 years ≤ age \< 70 years with severe aortic stenosis who have surgical contraindications or high risks, or have other risk factors such as post-chest radiotherapy, liver failure, diffuse severe aortic calcification, extreme weakness, etc., or patients refuse to undergo routine open-chest surgery; * 3\. The patient's anatomical structure is suitable for TAVR and can tolerate transesophageal ultrasound; * 4\. The patient has signed the informed consent form and is willing to participate in this study. Exclusion Criteria: * 1\. Imaging (ultrasound and/or CT and/or MRI) confirmed a lesion, thrombus or calculus in the left ventricle; * 2\. Severe obstruction of the left ventricular outflow tract; * 3\. Severe right ventricular dysfunction; * 4\. Acute myocardial infarction within 30 days before the procedure; * 5\. Active endocarditis history within 180 days before the procedure; * 6\. Inappropriate aortic root anatomy (such as combined aortic dissection, excessive aortic annulus, risk of coronary artery occlusion, etc.); * 7\. Severe calcification and distortion of the surgical approach; * 8\. Left ventricular ejection fraction less than 20%; * 9\. Other cardiac diseases that require concurrent treatment (such as severe mitral regurgitation, atrial fibrillation, etc.); * 10\. History of stroke or transient ischemic attack within 90 days before the procedure; * 11\. Liver cirrhosis or active liver disease; * 12\. Renal insufficiency (creatinine clearance rate \< 30 mL/min) and/or undergoing renal replacement therapy; * 13\. Unable to tolerate anticoagulation therapy during or after the procedure; * 14\. Participating in other drug or device research; * 15\. Any emergency or surgical operation within 30 days before the procedure; * 16\. Other severe comorbidities, even if the valve stenosis is corrected, the expected life expectancy is less than 1 year; * 17\. Other conditions deemed unsuitable for TAVR surgery by the cardiac team.
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
Beijing, Beijing Municipality, 100037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI turns routine heart tracings into an early warning for a silent valve disease
- Can a new heart valve offer a safer fix for aortic stenosis?
- Can Open-Heart surgery outperform a Tube-Based valve fix?
- Can a new heart valve restore quality of life?
- Does replacing a heart valve clear fluid from the lungs?
- AI ultrasound could unmask silent heart disease in seniors