An interventional study of Absnow II Absorbable Atrial Septal Defect Occluder System and Cera Atrial Septal Defect Occluder in Atrial Septal Defect, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Not yet recruiting. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Not applicable, Interventional, and Treatment
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.
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:
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.
84 studies on the registry are indexed under Heart Septal Defects, Atrial; 21 are open to participants now.
This study's planned enrollment of 236 is above the median of 100 across 50 interventional studies indexed under Heart Septal Defects, Atrial.
Browse Heart Septal Defects, Atrial studies →Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Absnow II Absorbable Atrial Septal Defect Occluder System
Device: Cera Atrial Septal Defect Occluder
To evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect.
The Cera atrial septal defect occluder produced by the same company serves as the control group.
Occlusion success rate
Time frame: 12 Months post-procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Heart Septal Defects, Atrial →
Lifetech Scientific (Shenzhen) Co., Ltd. →