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Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to independently do echo-guided percutaneous interventions and his cases should be more than 20 but less than 100. Experimental group is allocated to use novel interventional guidewire for echocardiography guided percutaneous interventions for ASD, control group will be treated by cook lunderquist guidewire. If echo-guided procedure does not work well, the procedure will be immediately replaced by conventional procedure guided by radiology. To evaluate the effectiveness and safety comprehensively, variables are defined as success rate, duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD. |
|
| Control Group | Active Comparator | Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guidewire for echo-guided interventions | Device | Under echocardiography guided treatment of ASD with a novel interventional guidewire |
|
| Measure | Description | Time Frame |
|---|---|---|
| success rate | The primary outcome will be the success rate, which is defined by the principles below:
| Immediately after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events(MAE) | MAE definition: Any complications related to devices or surgeries, including but not limited to: death, emergency surgery, severe cardiac tamponade requiring pericardiocentesis or operation, hemorrhage, stroke related to operation. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangbin Pan, MD,Ph.D | Contact | 010-88396666 | xiangbin428@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangbin Pan, MD,Ph.D | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Structural Heart Disease Center, Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32847382 | Derived | Kong P, Zhao G, Zhang Z, Zhang W, Fan T, Han Y, Pang K, Wang S, Zhang F, Wang W, Hu S, Pan X. Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009281. doi: 10.1161/CIRCINTERVENTIONS.120.009281. Epub 2020 Aug 27. |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| Cook lunderquist guidewire | Device | Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire. |
|
| Fuwai Huazhong Cardiovascular Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| Xinjiang People's Hospital | Active, not recruiting | Ürümqi | Xinjiang | China |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |