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

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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Chinese Academy of Medical Sciences, Fuwai Hospital

Conditions
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Ventricular Septal Defect

Intervention / Treatment
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* Device: Fully Absorbable VSD Occlusion System
* Device: VSD Occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up; Aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women; VSD effective shunt ≥3mm, ≤14mm; Distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation. Exclusion Criteria: Irreversible pulmonary vascular disease;Severe pulmonary hypertension with bidirectional shunt; Bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions; Sepsis or severe infection within 1 month prior to occlusion; Patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site; Cardiac malformation dependent on ventricular septal defect (VSD); Not suitable for treatment with this product.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD. | Device: Fully Absorbable VSD Occlusion System<br>* Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system<br>|
| Active Comparator: Control Group<br>Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD. | Device: VSD Occluder<br>* Under echocardiography guided treatment of VSD with commercially available occluder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success 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. | 6 months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Immediately after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VSD, Ventriculai Septal Defects, amplatzer