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

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: Not yet recruiting
• Conditions: Atrial Septal Defect
• Intervention / Treatment: Device: Absnow II Absorbable Atrial Septal Defect Occluder System; Device: Cera Atrial Septal Defect Occluder

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: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lifetech Technology (Shenzhen) Co., Ltd.; Phone Number: +8618500890555; Email: liuxiaoying@lifetechmed.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Occlusion success rate	12 Months post-procedure

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Collaborators: 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

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects, Atrial
• Other Study ID 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