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| Name | Class |
|---|---|
| Shanghai Shape Memory Alloy Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD. |
|
| Control Group | Active Comparator | Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully Absorbable VSD Occlusion System | Device | Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pan Xiangbin, MD, Ph.D | Contact | 010-88396666 | Xiangbin428@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pan Xiangbin, MD, Ph.D | Chinese Academy of Medical Science, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei high-tech cardiovascular hospital | Not yet recruiting | Hefei | Anhui | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2018 | Apr 30, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2018 | Apr 30, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006345 | Heart Septal Defects, Ventricular |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| VSD Occluder | Device | Under echocardiography guided treatment of VSD with commercially available occluder. |
|
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 |
| Structral Heart Disease Center, Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| The Second XIANGYA Hospital Of Central South University | Not yet recruiting | Hunan | Changsha | China |
|
| Children's Hospital Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | China |
|
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |