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Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
NA trial testing Absnow Absorbable ASD Closure System in Heart Septal Defects, Atrial in 165 participants. Completed in 30 August 2024.
| Lead sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 165 |
| Start date | 25 August 2018 |
| Primary completion | 28 August 2020 |
| Estimated completion | 30 August 2024 |
| Sites | 14 locations across China |
Lifetech Scientific (Shenzhen) Co., Ltd. — full company profile →
3 and older, any sex, with Heart Septal Defects, Atrial or Atrial Septal Defect. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Effective closure rate refers to proportion of patient without or with only mild-small residual shunt in TTE or TEE observation after device implantation
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group - Implanted | 158 |
Rate of common complication refers to proportion of subject with common complication during the 360day of follow up, common complications include Occluder dislocation, Moderate or larger residual shunt, High-grade atrioventricular block, Intractable headache or migraine, Cardiac tamponade, Cerebral embolism and Air embolism.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group - Implanted | 3 |
Immediate operation success refers to the occluder being successfully implanted which means left and right disks are effectively fixed on left and right sides of atrial septum, respectively and smoothly released without displacement or falling off and the delivery system and the delivery system is successfully withdrawn.Success rate refers to proportion of subject with such implant success.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group - Implanted | 159 |
This is one of the secondary safety endpoints, device-related AE rate refers to proportion of subject experienced device-related AEs
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group - Implant Attempted | 33 |
This is one of the secondary safety endpoints, device-related SAE rate refers to proportion of subject experienced device-related SAEs
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group - Implant Attempted | 10 |
Time frame: From enrollment until end of follow-up, up to 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment Group - Implant … |
|---|---|---|
| Cardiac septal defect residual shunt | Injury, poisoning and procedural complications | — |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | — |
| Pneumonia | Infections and infestations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | — |
| Infectious mononucleosis | Infections and infestations | — |
| Cellulitis | Infections and infestations | — |
| Renal abscess | Infections and infestations | — |
| Tonsillitis bacterial | Infections and infestations | — |
| Periodontitis | Infections and infestations | — |
| Pharyngeal abscess | Infections and infestations | — |
| Pharyngitis | Infections and infestations | — |
| Bronchitis | Infections and infestations | — |
| Mycoplasma infection | Infections and infestations | — |
| Pneumonia mycoplasmal | Infections and infestations | — |
| Contusion | Injury, poisoning and procedural complications | — |
| Spinal fracture | Injury, poisoning and procedural complications | — |
| Foetal disorder | Pregnancy, puerperium and perinatal conditions | — |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Colon cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Conjunctival neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Acne | Skin and subcutaneous tissue disorders | — |
| Metabolic acidosis | Metabolism and nutrition disorders | — |
| Gout | Metabolism and nutrition disorders | — |
| Intracranial aneurysm | Nervous system disorders | — |
| Reaction | System | Treatment Group - Implant … |
|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Headache | Nervous system disorders | — |
| Pyrexia | General disorders | — |
| Chest Pain | General disorders | — |
| Bronchitis | Infections and infestations | — |
| Vomiting | Gastrointestinal disorders | — |
| Viral upper respiratory tract infection | Infections and infestations | — |
| Cardiac septal defect residual shunt | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Cardiac septal defect residual shunt, Pregnancy, Pneumonia, Upper respiratory tract infection, Henoch-Schonlein purpura, Infectious mononucleosis, Cellulitis, Renal abscess.
Data from ClinicalTrials.gov NCT03601039 adverse events section.
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03601039.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing