An observational study in Atrial Septal Defect, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Active, not recruiting at 10 sites in 3 countries. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Observational
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The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
The study intends to collect data from patients who have implanted with the device in 2019 or later.
84 studies on the registry are indexed under Heart Septal Defects, Atrial; 21 are open to participants now.
This study's planned enrollment of 145 is above the median of 120 across 28 observational 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.
Counted across the registry records on this site, refreshed daily.
Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients did not conduct any follow up visit after hospital discharge.
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.
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.
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.
Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System
The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects.
Procedural success
Procedural success is defined as a composite of: 1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation. 2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation.
Time frame: 6 months post-implantation
Incidence of moderate or large residual shunt
Time frame: At procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of death
Time frame: From attempted procedure to 24 months post-implantation
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Oct 2026, 26 months.
Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Oct 2026, on Oct 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. 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. →