Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy

April 7, 2026 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control Group
Device: Cera Atrial Septal Defect Occluder
The Cera atrial septal defect occluder produced by the same company serves as the control group.
Experimental: Test Group
Device: Absnow II Absorbable Atrial Septal Defect Occluder System
To evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occlusion success rate
Time Frame: 12 Months post-procedure
12 Months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifetech Scientific (Shenzhen) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese PLA General Hospital
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
The Children's Hospital of Zhejiang University School of Medicine
Lanzhou University Second Hospital
Fuwai Yunnan Cardiovascular Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LT-P42CT(CN)-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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