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Could ultrasound replace X-Rays in heart valve surgery?

NCT ID NCT07317804

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 212 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.