View clinical trials related to Ventricular Septal Defect.
Filter by:The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.
The purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD. Clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. Prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.
With advances in interventional cardiac catheterization, ventricular septal defect (VSD) could be successfully treated via transcatheter device closure. Cardiac catheterization team of National Taiwan University Children's Hospital has recently treated more than 60 patients with VSD using this technique. Both treatment effect and follow-up results were encouraging. Of particular notice is that many patients experienced subjective improvement in exercise tolerance after VSD closure. Traditionally, VSD could only be repaired by open-heart surgery under cardiopulmonary bypass. Therefore, VSD closure would be considered only for those with moderate to large defect, significant heart failure, or presenting with significant exercise intolerance. With the success in transcatheter closure of VSD, a procedure which is safer and leading to faster recovery comparing to cardiac surgery, device closure of VSD would be a reasonable and sensible treatment of choice if it is beneficial for long-term cardiac function and exercise performance. This project will prospectively enroll 50 patients with VSDs subject to transcatheter closure of the defect in our institute. Before device closure and 6 months after closure, participants will be assessed with image studies (including speckle tracking and tissue Doppler echocardiography), measurements of serum biomarkers (including B-type natriuretic peptide and biomarkers of collagen metabolism), and standard cardiopulmonary exercise test. The purpose of this study is to investigate the potential benefits of closing VSD with respect to cardiac function and exercise performance, which might serve as basis to redefine future indication of VSD closure.