Dissolvable heart patch could spare patients from surgery
NCT ID NCT07529028
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
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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 236 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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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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3 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. 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
Only the study team decides who joins. These are the ways to reach them.
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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.
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Other studies related to the condition(s) this trial covers.
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