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.
1. This is a prospective, multicenter, randomized and noninferiority clinical trial, which is designed to compare the effectiveness and safety with the fully absorbable ventricular septal defect (VSD) occlusion system and VSD occlusion system produced by Shanghai shape memory alloy materials co., LTD. 2. This trial will recruit about 108 subjects from 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The proposal recruiting period is 12 months and the follow-up will be performed at 1 month, 3 months and 6 months after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
Under echocardiography guided treatment of VSD with commercially available occluder.
Hefei high-tech cardiovascular hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGStructral Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Second XIANGYA Hospital Of Central South University
Hunan, Changsha, China
NOT_YET_RECRUITINGChildren's Hospital Nanjing Medical University
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGsuccess rate of occlusion at 6 months after the surgery
Successful occlusion is that when follow-up under echocardiography at 6 months after surgery, the occlusion site shows no residual shunt or only a small amount of residual shunt.
Time frame: 6 months after the surgery
Surgical technique success rate
After the occluder was implanted with surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely.
Time frame: Immediately after surgery
technique success rate
After the occluder was implanted with occluder and surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely and no occluder detachment occurred during the operation.
Time frame: Immediately after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.