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Dissolvable heart patch offers hope for kids with hole in the heart

NCT ID NCT03601039

Disease control Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new device called Absnow that can close a common type of hole in the heart (atrial septal defect) and then dissolve over time. 165 patients, including children as young as 3, received the device. The goal was to see if it safely closes the hole without major problems like the device moving or causing irregular heartbeats.

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

165 people

The number who actually took part.

Started

Aug 2018

Finished

Aug 2024

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: * Age ≥3 , weight ≥10Kg * Secundum left-to-right shunt ASD with hemodynamic significance * Distance from the defect edge to coronary vein sinus, superior and inferior vena cava, pulmonary vein≥5mm and AV valve should be ≥7mm * The atrial septum length (stretched diameter) should be greater than the diameter of left disk Exclusion Criteria: * Patients of primum, venous sinus and coronary sinus ASD * Patients with atrial septum defect ≥26mm * Patients with other structural heart disease in addition to ASD * Patients with complication of obstructive pulmonary arterial hypertension, Eisenmenger syndrome * Infective endocarditis patients * Patients with hemolysis or hemorrhagic disease, unhealed ulcer or any taboo about aspirin (except being able to take other anti-platelet agent for consecutive six months) within one month before implantation * Patients with thrombosis(especially in left atrium or left atrial appendage thrombus) as shown by echocardiography * Patients with known condition of hypercoagulation status * Patients who have undergone heart surgery in the past * Patients allergic to PLLA * Patients refusing to sign the informed consent form * Patients with poor compliance on disease-related treatment and poor cooperation on follow-up visits * Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive pregnancy test result during the screening period * Patients that have participated in any clinical trial that may affect the evaluation of the device in this trial and not completed or withdrawn from the previous clinical trial within 3 months prior to this trial screening period * The patients considered to be not eligible for this clinical trial by the investigator

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Conditions

The condition(s) this trial relates to.

atrial septal defect

As listed by the trial registrant

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

Atrial septal defect Heart septal defects, atrial

Contacts and locations

Locations

  • Children's Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Fuwai Central China Cardiovascular Hospital

    Zhenzhou, Henan, China

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, China

  • Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Shenzhen Children's Hospital

    Shenzhen, Shenzhen, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

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