The efficacy and safety of percutaneous atrial septal defect occlusion under transthoracic echocardiography guidance only—— A prospective single center study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075696

Enrollment

Unknown

Registered

2023-09-13

Start date

2023-09-19

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial septal defect

Interventions

TTE group:percutaneous closure of atrial septal defects under the guidance of transthoracic echocardiography

Eligibility

Sex/Gender

All

Age

2 Years to No maximum

Inclusion criteria

Inclusion criteria: 1: Age=2yrs 2: Weight=8kg 3: Congenital isolated secundum ASD 4: Diameter of defect=8mm, =38mm 5: Distance from the edge of the defect to inferior vena cava is =, to atrioventricular valve is = 7mm 6: Length of ASD = length of left disc of occluder 7: Subjects who can understand the trial purpose and sign the informed consent and are willing to undergo relevant examinations and clinical follow-up .

Exclusion criteria

Exclusion criteria: 1: Ostium primum ASD, sinus venosus ASD and multi-hole ASD 2: With severe cardiac structural abnormalities that need surgical correction 3: Severe pulmonary hypertension, and transthoracic ultrasound suggested a right-to-left shunt at the atrial level 4: Intra-cardiac or venous thrombosis 5: Combined with infective endocarditis or bleeding risk 6: Suffering from infectious diseases within one month

Design outcomes

Primary

Measure	Time frame
The success rate of occlusion;	—

Secondary

Measure	Time frame
The rates of adverse events before discharge and during follow-up (3 months after surgery), including occluder dislodgment; moderate or above pericardial effusion; cardiac perforation; occluder related atrioventricular valve regurgitation; infective endocarditis; severe arrhythmia (Junctional rhythm, ii ° iii ° atrioventricular block, left bundle branch block); stroke ;Device time;Utilization rate of each section of transthoracic ultrasound;Utilization rate of the different occluder release methods;Clarity classification of all sections of intraoperative transthoracic echocardiography;Proportion of intraoperative transesophageal echocardiography guidance ;Changes in right heart function;	—

Measure

Time frame

The rates of adverse events before discharge and during follow-up (3 months after surgery), including occluder dislodgment; moderate or above pericardial effusion; cardiac perforation; occluder related atrioventricular valve regurgitation; infective endocarditis; severe arrhythmia (Junctional rhythm, ii ° iii ° atrioventricular block, left bundle branch block); stroke ;Device time;Utilization rate of each section of transthoracic ultrasound;Utilization rate of the different occluder release methods;Clarity classification of all sections of intraoperative transthoracic echocardiography;Proportion of intraoperative transesophageal echocardiography guidance ;Changes in right heart function;

—

Countries

China

Contacts

Public ContactLiu Liu Huang

Department of Cardiothoracic Surgery, The First Affiliated Hospital of Guangxi Medical University

dochuangllgxnn@sr.gxmu.edu.cn+86 185 7778 0131

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026