Atrial Septal DefectNCT07529028
Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy
A study testing Absnow II Absorbable Atrial Septal Defect Occluder System and Cera Atrial Septal Defect Occluder in people with Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd..
Trial summary
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- Absnow II Absorbable Atrial Septal Defect Occluder System and Cera Atrial Septal Defect Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged≥3years, body weight≥10 kg, regardless of gender;
- Patients with secundum atrial septal defect (ASD) with left-to-right shunt and evidence of right ventricular volume overload (echocardiography indicating right ventricular enlargement);
- ASD diameter≥5 mm and<26 mm;
- 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;
- Patients who can understand the trial purpose, voluntarily participate and sign the informed consent form, and are willing to cooperate with follow-up completion.
Who cannot join
- Primum, sinus venosus, and unroofed coronary sinus types of atrial septal defect (ASD);
- Patients with ASD diameter≥26 mm;
- Combined with other structural heart diseases requiring treatment besides ASD;
- Complicated with severe pulmonary hypertension or Eisenmenger syndrome;
- Patients who suffered from infectious diseases within 1 month before enrollment, including infective endocarditis, or those with uncontrolled infectious diseases;
- 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);
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- Intracardiac thrombus detected by echocardiography (especially thrombus in the left atrium or left atrial appendage), or venous thrombosis at the catheter insertion site;
- Patients allergic to the materials of the investigational medical device;
- Pregnant or lactating females, or those who plan to have children during the trial and are unwilling to adopt effective contraceptive measures;
- Patients who participated in other drug or medical device clinical trials before enrollment and have not reached the primary endpoint;
- Patients with other factors deemed inappropriate to participate in this clinical trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the AbsnowTM II Absorbable Atrial Septal Defect Occluder System for Atrial Septal Defect Closure Therapy
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy. A parallel controlled comparison will be conducted using the Cera atrial septal defect occluder manufactured by the same company as the control device, to evaluate the safety and efficacy of the AbsnowTM II absorbable ASD occluder system in the treatment of ASD occlusion.
Read the detailed description
This study is expected to be conducted at multiple centers, adopting a prospective, multicenter, randomized controlled, non-inferiority design, and is divided into the following two phases:
- Roll-in Phase: Each study center may enroll 1 to 3 roll-in subjects. Investigators will implant the absorbable atrial septal defect occluder system to gain procedural familiarity with the investigational device. (Roll-in subjects will not be included in the confirmatory trial statistical analysis.)
- Confirmatory Trial: A prospective, multicenter, randomized controlled, non-inferiority trial design will be adopted. A total of 236 eligible subjects are planned for enrollment. Qualified subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group. Subjects in the test group will receive treatment with the absorbable atrial septal defect occluder system manufactured by Lifetech Scientific (Shenzhen) Co., Ltd. Subjects in the control group will receive treatment with the Cera atrial septal defect occluder manufactured by the same company.
All subjects will undergo assessments at screening, pre-discharge, and follow-up visits at 1 month, 3 months, 6 months, and 12 months post-procedure. A clinical summary will be prepared after completion of all 12-month follow-up evaluations to support product registration application. After trial completion, all subjects will be followed long-term for 2 to 5 years to evaluate the long-term safety of the device.
- Conditions
- Atrial Septal Defect
- Being tested
- Absnow II Absorbable Atrial Septal Defect Occluder System, Cera Atrial Septal Defect Occluder
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absnow II Absorbable Atrial Septal Defect Occluder SystemDevice
To evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect.
Cera Atrial Septal Defect OccluderDevice
The Cera atrial septal defect occluder produced by the same company serves as the control group.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Device: Absnow II Absorbable Atrial Septal Defect Occluder System |
| Control Group | Other | Not described Receives: Device: Cera Atrial Septal Defect Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion success rate
Measured: 12 Months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Fuwai Yunnan Cardiovascular Hospital, Guangdong Provincial People's Hospital, Chinese PLA General Hospital, Lanzhou University Second Hospital, The Children's Hospital of Zhejiang University School of Medicine, Beijing Anzhen Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529028
- Sponsor's protocol ID
- LT-P42CT(CN)-01
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the AbsnowTM II Absorbable Atrial Septal Defect Occluder System for Atrial Septal Defect Closure Therapy
- ClinicalTrials.gov ID
- NCT07529028
- Acronym / sponsor ID
- LT-P42CT(CN)-01
- Conditions
- Atrial Septal Defect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Fuwai Yunnan Cardiovascular Hospital, Guangdong Provincial People's Hospital, Chinese PLA General Hospital, Lanzhou University Second Hospital, The Children's Hospital of Zhejiang University School of Medicine, Beijing Anzhen Hospital
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy. A parallel controlled comparison will be conducted using the Cera atrial septal defect occluder manufactured by the same company as the control device, to evaluate the safety and efficacy of the AbsnowTM II absorbable ASD occluder system in the treatment of ASD occlusion.
Detailed description
This study is expected to be conducted at multiple centers, adopting a prospective, multicenter, randomized controlled, non-inferiority design, and is divided into the following two phases:
- Roll-in Phase: Each study center may enroll 1 to 3 roll-in subjects. Investigators will implant the absorbable atrial septal defect occluder system to gain procedural familiarity with the investigational device. (Roll-in subjects will not be included in the confirmatory trial statistical analysis.)
- Confirmatory Trial: A prospective, multicenter, randomized controlled, non-inferiority trial design will be adopted. A total of 236 eligible subjects are planned for enrollment. Qualified subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group. Subjects in the test group will receive treatment with the absorbable atrial septal defect occluder system manufactured by Lifetech Scientific (Shenzhen) Co., Ltd. Subjects in the control group will receive treatment with the Cera atrial septal defect occluder manufactured by the same company.
All subjects will undergo assessments at screening, pre-discharge, and follow-up visits at 1 month, 3 months, 6 months, and 12 months post-procedure. A clinical summary will be prepared after completion of all 12-month follow-up evaluations to support product registration application. After trial completion, all subjects will be followed long-term for 2 to 5 years to evaluate the long-term safety of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Absnow II Absorbable Atrial Septal Defect Occluder System |
| Control Group | Other | Device: Cera Atrial Septal Defect Occluder |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged≥3years, body weight≥10 kg, regardless of gender;
- Patients with secundum atrial septal defect (ASD) with left-to-right shunt and evidence of right ventricular volume overload (echocardiography indicating right ventricular enlargement);
- ASD diameter≥5 mm and<26 mm;
- 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;
- Patients who can understand the trial purpose, voluntarily participate and sign the informed consent form, and are willing to cooperate with follow-up completion.
Key exclusion criteria (11 listed)
- Primum, sinus venosus, and unroofed coronary sinus types of atrial septal defect (ASD);
- Patients with ASD diameter≥26 mm;
- Combined with other structural heart diseases requiring treatment besides ASD;
- Complicated with severe pulmonary hypertension or Eisenmenger syndrome;
- Patients who suffered from infectious diseases within 1 month before enrollment, including infective endocarditis, or those with uncontrolled infectious diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absnow II Absorbable Atrial Septal Defect Occluder SystemTo evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect. | Device | Test Group |
| Cera Atrial Septal Defect OccluderThe Cera atrial septal defect occluder produced by the same company serves as the control group. | Device | Control Group |
Primary outcome
Occlusion success rate
Time frame: 12 Months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Absnow II Absorbable Atrial Septal Defect Occluder System and Cera Atrial Septal Defect Occluder in people with Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lifetech Technology (Shenzhen) Co., Ltd. (+8618500890555, liuxiaoying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion success rate (time frame: 12 Months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.