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

Ventricular Septal Defect Clinical Trial

Official title:

Chinese Academy of Medical Sciences, Fuwai Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941691
• Other study ID #: WQKJJ001
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Ventricular Septal Defect

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