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Heart hole repair without X-Rays: major trial launches

NCT ID NCT07054541

Disease control Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This large study tests whether closing a common heart hole (atrial septal defect) using only ultrasound guidance and special tools is as good as the standard X-ray method. The goal is to avoid radiation and contrast dye risks, such as cancer and kidney injury. About 666 participants will be randomly assigned to either the ultrasound or X-ray group, and a separate group of patients who cannot have X-rays will also be studied.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ultrasound-guided procedure with specialized instruments
What this could lead to
If successful, this could offer a safer, radiation-free and contrast-free way to close heart holes, reducing long-term cancer risk and allowing treatment for pregnant women and those with allergies or kidney problems.
What could go wrong
This is a Phase 4 trial, but it is not yet recruiting. The ultrasound method may not be as effective as the standard X-ray method in all cases, and the specialized instruments may not work for every patient.

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 666 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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

2 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.

RCT Eligibility Criteria Inclusion Criteria: * Age ≥ 2 years * Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload * The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm Exclusion Criteria: * Pregnant women * Contrast agent allergy * Renal insufficiency * Associated cardiac malformations requiring surgical intervention * Right-to-left shunt ASD * Ostium primum ASD and sinus venosus ASD * Any severe infection within one month before the procedure * Intracardiac thrombus Cohort Eligibility Criteria： Inclusion Criteria: * Age ≥ 2 years * Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload * The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm * Contraindications to radiation exposure or refusal to undergo fluoroscopy-guided procedures Exclusion Criteria: * Associated cardiac malformations requiring surgical intervention * Right-to-left shunt ASD * Ostium primum ASD and sinus venosus ASD * Any severe infection within one month before the procedure * Intracardiac thrombus

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Conditions

The condition(s) this trial relates to.

atrial septal defect atrial septal defect, ostium secundum type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial septal defect (ASD)

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 Municipality, 100037, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.