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

NCT07529028 | Not Yet Recruiting

• 1 other identifier: LT-P42CT(CN)-01
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Atrial Septal Defect

Outcome Measures

Primary Outcomes (1)

• Occlusion success rate

  12 Months post-procedure

Study Arms (2)

Test Group

EXPERIMENTAL

Device: Absnow II Absorbable Atrial Septal Defect Occluder System

Control Group

OTHER

Device: Cera Atrial Septal Defect Occluder

Interventions

Absnow II Absorbable Atrial Septal Defect Occluder System DEVICE

To evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect.

Test Group

Cera Atrial Septal Defect Occluder DEVICE

The Cera atrial septal defect occluder produced by the same company serves as the control group.

Control Group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Lifetech Scientific (Shenzhen) Co., Ltd.: lead
• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Lanzhou University Second Hospital: collaborator
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• Beijing Anzhen Hospital: collaborator

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Lifetech Technology (Shenzhen) Co., Ltd.

CONTACT

+8618500890555; liuxiaoying@lifetechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 14, 2026

Record last verified: 2025-12