Clinical trial NCT03941691: A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure
Official title: Chinese Academy of Medical Sciences, Fuwai Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventricular Septal Defect
Keywords: VSD
Ventriculai Septal Defects
amplatzer
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Shape Memory Alloy Co., Ltd.
First posted: 2019-05-08
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: success rate of occlusion at 6 months after the surgery
timeFrame: 6 months after the surgery
Secondary outcomes:
measure: Surgical technique success rate
timeFrame: Immediately after surgery
measure: technique success rate
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Hefei
country: China
facility: Hefei high-tech cardiovascular hospital
state: Anhui
city: Beijing
country: China
facility: Structral Heart Disease Center, Fuwai Hospital
state: Beijing
city: Hunan
country: China
facility: The Second XIANGYA Hospital Of Central South University
state: Changsha
city: Nanjing
country: China
facility: Children's Hospital Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Medical Science, Fuwai Hospital
name: Pan Xiangbin, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: