A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure
NCT ID: NCT03941691
Last Updated: 2019-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2019-04-11
2021-04-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD.
Fully Absorbable VSD Occlusion System
Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
Control Group
Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD.
VSD Occluder
Under echocardiography guided treatment of VSD with commercially available occluder.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
1 Year
60 Years
ALL
No
Sponsors
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Shanghai Shape Memory Alloy Co., Ltd.
UNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Pan Xiangbin
Principal Investigator
Principal Investigators
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Pan Xiangbin, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Science, Fuwai Hospital
Locations
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Hefei high-tech cardiovascular hospital
Hefei, Anhui, China
Structral Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality, China
The Second XIANGYA Hospital Of Central South University
Hunan, Changsha, China
Children's Hospital Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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WQKJJ001
Identifier Type: -
Identifier Source: org_study_id
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