Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results
Not Applicable
- Conditions
- Atrial septal Defect
- Registration Number
- JPRN-UMIN000047888
- Lead Sponsor
- PS Institute of Cardiology Department of Cardiology
- Brief Summary
Efficacy 312(97.5%) Safety 312(97.5%) Mean Procedural time (mins) 23.5 Mean Fluoroscopy time (mins) 6.8 Periprocedural complications 27 (8.4%) Cardiac death 0 (0%) Device embolization 2 (0.6%) Cardiac perforation 1 (0.3%) Pericardial effusion 3 (0.9%) Transient supraventricular arrhythmias 15 (4.6%) Transient atrioventricular block 6 (1.8%) Local site hematoma 0 (0%) Stroke 0 (0%) Transient headache 8 (2.5%) Closure rate 312 (100%) Late embolization 0 (0%) Erosion 0(0%) Residual shunting 2 (0.6%)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method