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Dissolvable heart patch could spare patients from surgery

NCT ID NCT07529028

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests a new device called Absnow II that closes a common heart hole (atrial septal defect) and then dissolves over time. About 236 people with a hole between 5 and 26 mm will get either the new device or a standard one. The goal is to see if the new device works just as well and is safe, potentially avoiding the need for lifelong implants.

What this could mean

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

Active substance
Absnow II absorbable atrial septal defect occluder (a device that closes a hole in the heart and then dissolves over time)
What this could lead to
If successful, this could offer a safer, less invasive way to close certain heart holes, with the device dissolving after the hole heals, potentially reducing long-term risks.
What could go wrong
This is an early-stage trial with only 236 participants, so results may not apply to everyone. The device might not close the hole as effectively or could cause complications like blood clots or device movement.

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

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

About 236 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

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

3 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. Aged≥3years, body weight≥10 kg, regardless of gender; 2. Patients with secundum atrial septal defect (ASD) with left-to-right shunt and evidence of right ventricular volume overload (echocardiography indicating right ventricular enlargement); 3. ASD diameter≥5 mm and\<26 mm; 4. The distance from the ASD rim to the openings of the superior/inferior vena cava and pulmonary veins≥5mm, and the distance to the atrioventricular valve≥7mm; 5. Patients who can understand the trial purpose, voluntarily participate and sign the informed consent form, and are willing to cooperate with follow-up completion. Exclusion Criteria: 1. Primum, sinus venosus, and unroofed coronary sinus types of atrial septal defect (ASD); 2. Patients with ASD diameter≥26 mm; 3. Combined with other structural heart diseases requiring treatment besides ASD; 4. Complicated with severe pulmonary hypertension or Eisenmenger syndrome; 5. Patients who suffered from infectious diseases within 1 month before enrollment, including infective endocarditis, or those with uncontrolled infectious diseases; 6. Patients who suffered from hemolysis, hemorrhagic diseases, unhealed peptic ulcer within 1 month before enrollment, or have any contraindications to aspirin therapy (except those who can take other antiplatelet drugs continuously for 6 months); 7. Intracardiac thrombus detected by echocardiography (especially thrombus in the left atrium or left atrial appendage), or venous thrombosis at the catheter insertion site; 8. Patients allergic to the materials of the investigational medical device; 9. Pregnant or lactating females, or those who plan to have children during the trial and are unwilling to adopt effective contraceptive measures; 10. Patients who participated in other drug or medical device clinical trials before enrollment and have not reached the primary endpoint; 11. Patients with other factors deemed inappropriate to participate in this clinical trial 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

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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