NCT03941691

A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure

Chinese Academy of Medical Sciences, Fuwai Hospital

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ventricular Septal Defect

Interventions

Type	Name	Description
DEVICE	Fully Absorbable VSD Occlusion System	Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
DEVICE	VSD Occluder	Under echocardiography guided treatment of VSD with commercially available occluder.

Timeline

• Start date: 2019-04-11
• Primary completion: 2021-04-20
• Completion: 2021-04-20
• First posted: 2019-05-08
• Last updated: 2019-05-08

Locations

4 sites across 1 country: China