Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results

Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results - Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047888

Enrollment

320

Registered

2022-05-29

Start date

2012-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Atrial septal Defect

Interventions

Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder (Vascular Innovation, Thailand)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with atrial septal defect more than 4 year old with 1, echocardiographic evidence of right ventricular volume overload. 2, significant left to right shunt 3,maximum diameter of ASD less than 40 mm with adequate rims.

Exclusion criteria

Exclusion criteria: Aanomalous pulmonary venous connection, Associated complex cardiac anomaly, Eisenmenger syndrome, Impaired left ventricular systolic function, and Inadequate (<4mm) inferior vena cava (IVC) rim

Design outcomes

Primary

Measure	Time frame
Efficacy: successful closure of defect without significant shunt (not more than mild) on six months of follow-up. Saftey: successful deployment without either major peri-procedural complications (death, device embolization, cardiac perforation, pericardial effusion, stroke, infective endocarditis, atrioventricular block) or late embolization, erosion, and residual shunting on follow up.	—

Secondary

Measure	Time frame
Death, device embolization, cardiac perforation, pericardial effusion, stroke, infective endocarditis, atrioventricular block, late embolization, erosion, and residual shunting.	—

Countries

Asia(except Japan)

Contacts

Public ContactNajeeb Sofi

LPS institute of Cardiology Department of Cardiology

sofinajeeb@gmail.com0091-7042132737

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026