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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03941691
Other study ID # WQKJJ001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2019
Est. completion date April 20, 2021

Study information

Verified date May 2019
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Pan Xiangbin, MD, Ph.D
Phone 010-88396666
Email Xiangbin428@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date April 20, 2021
Est. primary completion date April 20, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 60 Years
Eligibility Inclusion Criteria:

1. 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;

2. Aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women;

3. VSD effective shunt =3mm, =14mm;

4. 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:

1. Irreversible pulmonary vascular disease;Severe pulmonary hypertension with bidirectional shunt;

2. Bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions;

3. Sepsis or severe infection within 1 month prior to occlusion;

4. Patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site;

5. Cardiac malformation dependent on ventricular septal defect (VSD);

6. Not suitable for treatment with this product.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fully Absorbable VSD Occlusion System
Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
VSD Occluder
Under echocardiography guided treatment of VSD with commercially available occluder.

Locations

Country Name City State
China Structral Heart Disease Center, Fuwai Hospital Beijing Beijing
China Hefei high-tech cardiovascular hospital Hefei Anhui
China The Second XIANGYA Hospital Of Central South University Hunan Changsha
China Children's Hospital Nanjing Medical University Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital Shanghai Shape Memory Alloy Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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