Trial Outcomes & Findings for Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients (NCT NCT03601039)

Last Updated: 2026-03-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

165 participants

Primary outcome timeframe

360-day post operation

Results posted on

2026-03-10

Participant Flow

A total of 179 subjects were screened, of which 165 were successfully enrolled.

Participant milestones

Participant milestones
Measure	Absnow™ Absorbable ASD Closure System Participant underwent transcatheter implantation of investigational device
Overall Study STARTED	165
Overall Study Implant Attempt	164
Overall Study Implanted with the study device (FAS)	161
Overall Study Completed discharge visit	159
Overall Study Completed 30d visit	159
Overall Study Completed 90d visit	159
Overall Study Completed 180d visit	159
Overall Study Completed 360d visit	159
Overall Study Completed 2y visit	157
Overall Study Completed 3y visit	153
Overall Study Completed 4y visit	152
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Absnow™ Absorbable ASD Closure System n=161 Participants All subjects implanted with Absnow Absorbable ASD Occluder.
Age, Continuous	16.82 years STANDARD_DEVIATION 17.74 • n=161 Participants
Sex: Female, Male Female	96 Participants n=161 Participants
Sex: Female, Male Male	65 Participants n=161 Participants
Region of Enrollment China	161 participants n=161 Participants

PRIMARY outcome

Timeframe: 360-day post ASD closure operative

Effective closure rate refers to proportion of patient without or with only mild-small residual shunt in TTE or TEE observation after device implantation

Outcome measures

Outcome measures
Measure	Treatment Group - Implanted n=161 Participants Among all enrolled patients (165), subject without implant attempt (1) and with failed implant attempt (3) were excluded, leaving 161 subjects for this endpoint analysis.
Effective Closure Rate at 360-day Post Operation	158 Participants

PRIMARY outcome

Timeframe: 360-day post operation

Outcome measures

Outcome measures
Measure	Treatment Group - Implanted n=161 Participants Among all enrolled patients (165), subject without implant attempt (1) and with failed implant attempt (3) were excluded, leaving 161 subjects for this endpoint analysis.
The Rate of Common Complication During 360-day Post ASD Closure Operative	3 Participants

SECONDARY outcome

Timeframe: Immediate postoperative

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.

Outcome measures

Outcome measures
Measure	Treatment Group - Implanted n=161 Participants Among all enrolled patients (165), subject without implant attempt (1) and with failed implant attempt (3) were excluded, leaving 161 subjects for this endpoint analysis.
Immediate Operation Success Rate	159 Participants

SECONDARY outcome

Timeframe: 5 years post operation

This is one of the secondary safety endpoints, device-related AE rate refers to proportion of subject experienced device-related AEs

Outcome measures

Outcome measures
Measure	Treatment Group - Implanted n=164 Participants Among all enrolled patients (165), subject without implant attempt (1) and with failed implant attempt (3) were excluded, leaving 161 subjects for this endpoint analysis.
Device-related AE (Adverse Event) Rate	33 Participants

SECONDARY outcome

Timeframe: 5 years post operation

This is one of the secondary safety endpoints, device-related SAE rate refers to proportion of subject experienced device-related SAEs

Outcome measures

Outcome measures
Measure	Treatment Group - Implanted n=164 Participants Among all enrolled patients (165), subject without implant attempt (1) and with failed implant attempt (3) were excluded, leaving 161 subjects for this endpoint analysis.
Device-related SAE (Serious Adverse Event) Rate	10 Participants

Adverse Events

Treatment Group - Implant Attempted

Serious events: 38 serious events

Other events: 126 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group - Implant Attempted n=164 participants at risk Among all enrolled patients (165), subject without implant attempt (1) was excluded, leaving 164 subjects for tracking AEs throughout their study periods.
Surgical and medical procedures Atrial septal defect repair	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Surgical and medical procedures Hernia hiatus repair	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Respiratory, thoracic and mediastinal disorders Epistaxis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Respiratory, thoracic and mediastinal disorders Snoring	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Gastrointestinal disorders Chronic gastritis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Gastrointestinal disorders Gastrooesophageal reflux disease	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Gastrointestinal disorders Cyclic vomiting syndrome	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Cardiac disorders Atrial tachycardia	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Cardiac disorders Supraventricular extrasystoles	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Product Issues Device dislocation	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Hepatobiliary disorders Cholelithiasis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Investigations Myocardial necrosis marker increased	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Congenital, familial and genetic disorders Atrial septal defect	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Psychiatric disorders Major depression	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Blood and lymphatic system disorders Lymphadenitis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Eye disorders Photoelectric conjunctivitis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Metabolism and nutrition disorders Gout	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Nervous system disorders Intracranial aneurysm	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Bronchitis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Nervous system disorders Headache	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Mycoplasma infection	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Pneumonia mycoplasmal	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Injury, poisoning and procedural complications Cardiac septal defect residual shunt	4.9% 8/164 • From enrollment until end of follow-up, up to 5 years
Injury, poisoning and procedural complications Contusion	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Injury, poisoning and procedural complications Spinal fracture	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Pregnancy, puerperium and perinatal conditions Pregnancy	3.0% 5/164 • From enrollment until end of follow-up, up to 5 years
Pregnancy, puerperium and perinatal conditions Foetal disorder	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage 0	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Conjunctival neoplasm	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	1.2% 2/164 • From enrollment until end of follow-up, up to 5 years
Skin and subcutaneous tissue disorders Acne	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Metabolism and nutrition disorders Metabolic acidosis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Pneumonia	2.4% 4/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Upper respiratory tract infection	1.8% 3/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Infectious mononucleosis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Cellulitis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Renal abscess	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Tonsillitis bacterial	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Periodontitis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Pharyngeal abscess	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Pharyngitis	0.61% 1/164 • From enrollment until end of follow-up, up to 5 years

Other adverse events

Other adverse events
Measure	Treatment Group - Implant Attempted n=164 participants at risk Among all enrolled patients (165), subject without implant attempt (1) was excluded, leaving 164 subjects for tracking AEs throughout their study periods.
Infections and infestations Upper respiratory tract infection	20.7% 34/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Bronchitis	7.9% 13/164 • From enrollment until end of follow-up, up to 5 years
Infections and infestations Viral upper respiratory tract infection	6.7% 11/164 • From enrollment until end of follow-up, up to 5 years
Respiratory, thoracic and mediastinal disorders Cough	12.8% 21/164 • From enrollment until end of follow-up, up to 5 years
General disorders Pyrexia	9.8% 16/164 • From enrollment until end of follow-up, up to 5 years
General disorders Chest Pain	8.5% 14/164 • From enrollment until end of follow-up, up to 5 years
Injury, poisoning and procedural complications Cardiac septal defect residual shunt	6.1% 10/164 • From enrollment until end of follow-up, up to 5 years
Nervous system disorders Headache	10.4% 17/164 • From enrollment until end of follow-up, up to 5 years
Gastrointestinal disorders Vomiting	7.3% 12/164 • From enrollment until end of follow-up, up to 5 years

Additional Information

Shiting Li

Lifetech Scientific (Shenzhen) Co., Ltd.

Phone: +86 13699714609

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place