A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
Heart Septal Defects, Ventricular, Double Outlet Right Ventricle, Noncommitted VSD, Double Outlet Right Ventricle, Subaortic VSD
About this trial
This is an interventional treatment trial for Heart Septal Defects, Ventricular focused on measuring Infundibular Ventricular Septal Defect, occlusion, TEE-guided, asymmetric occluder, surgical repair
Eligibility Criteria
Inclusion Criteria:
(1) patients with single IVSD indicated by TTE,without concomitant cardiac malformation, serious arrhythmia or other important non-cardiac diseases;(2) patients whose ventricular septal defects from aortic residual < 3 mm, preoperative without aortic regurgitation or only mild reflux, defect size ≤10 mm;
Exclusion Criteria:
(1) defect size > 10 mm in diameter; (2) Preoperative with above moderate aortic valve prolapse (or) closed incompletely; (3) Eisenmenger syndrome caused by pulmonary hypertension,(4)decide temporarily to change method before surgery;(5) not signed informed consent application
Sites / Locations
- Surgery Building of 1st Affiliated Hospital of Nanchang University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TPDC group
SR group
Patients who matched inclusion criteria and randomly divided into TPDC group underwent the TEE-guided perventricular device closure without CBP. But of them,who underwent TPDC failure during the procedure would be dropped out of the trial.
Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP.