Ventricular Septal Defect Clinical Trial
Official title:
Chinese Academy of Medical Sciences, Fuwai Hospital
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.
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