Clinical trial of percutaneous closure of atrial septal defect

Clinical trial of percutaneous closure of atrial septal defect under the guidance of echocardiography

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13004246

Enrollment

Unknown

Registered

2013-11-07

Start date

2014-01-07

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

atrial septal defect

Interventions

radiation group:percutaneous closure of atrial septal defects under the guidance of radiation

TEE group:percutaneous closure of atrial septal defects under the guidance of transesophageal echocardiography

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

Eligibility

Sex/Gender

All

Age

2 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged = 2 years; 2. Ostium secundum ASD with diameter =5 mm and =36mm, which increases the right ventricular volume load; 3. Distance from the edge of the defect to superior vena cava, inferior vena cava, coronary sinus, and pulmonary vein =5 mm; and distance from the edge of the defect to the atrioventricular valve =7 mm; 4. Diameter of atrial septum larger than the left atrial side diameter of the selected occluder; 5. No combining with other disease requiring surgery.

Exclusion criteria

Exclusion criteria: 1. Ostium primum ASD and sinus venosus ASD; 2. Endocarditis; 3. Formation of the venous thrombus at the occluder and catheter insertion point; 4. Shunt from right to left caused by severe pulmonary arterial hypertension; 5. Associated with serious cardiomyopathy or valvular diseases irrelevant with ASD; 6. Suffering from infectious diseases within one month; 7. Hemorrhagic disease or uncured stomach ulcer; 8. Formation of the venous thrombus at the left atrium or left atrial appendage, partly or total anomalous pulmonary venous connection, left atrial septum, dysplasia of left atrial or ventricular.

Design outcomes

Primary

Measure	Time frame
Success rate of percutaneous closure of atrial septal defects;	—

Secondary

Measure	Time frame
Percutaneous ASD closure of postoperative adverse events occurred major vascular injury; heart hole; cardiac tamponade; damage the tricuspid valve reflux; radiation exposure; arrhythmia; The closurer fall off or deformation; thrombosis; embolism; hemolysis, postoperative residual shunt; infective endocarditis; after blocking noise;Breathing machine time; The length of hospitalization; cost;	—

Contacts

Public ContactXiangbin Pan

National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

xiangbin428@hotmail.com+86 13811763898

Outcome results

None listed

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