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A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion. Compared with the traditional atrial septal occluder, this new atrial septal occluder supports re-puncture after occluder implantation. Thus those patients who have undergone atrial septal defect closure with the novel device may be eligible for future radiofrequency ablation of atrial fibrillation or mitral valve intervention.
The trial is expected to enroll 128 patients who will be randomly assigned to the test group or control group in a 1:1 ratio. Patients in test group will received ReAces occluder,and the others the regular occluder.The experiment is scheduled to enroll 128 patients who will be randomly allocated to one of two groups: test or control. Patients in the test group will receive a ReAces occluder, while those in the control group will receive a standard occluder.The safety and efficacy of the two groups at 1 year after surgery will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients with ASD assigned to experimental group will receive the novel ASD occluder (ReAces) |
|
| Control Group | Active Comparator | Patients with ASD assigned to control group will receive the normal occluder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASD closure with the novel occluder (ReAces) | Device | Transcatheter closure atrial septal defect with the novel occluder (ReAces) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful rate of complete closure of atrial septal defect | The success rate of complete closure at 12 months after the procedure was used as the main efficacy index to evaluate the effectiveness of the novel atrial septal defect occluder ReAces, reflecting the long-term implantation effect of the device. | 0-360 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | all cause and cardiovascular mortality, pericardial tamponade, cerebrovascular events, malignant arrhythmia, infection, device migration, and occluder-related thrombosis or embolization during the operation or follow up. | 0-360 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenzhi Pan, Dr | Contact | +86 13774475922 | peden@sina.com | |
| Junbo Ge, Dr | Contact | +86 13901977506 | ge.junbo@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39734195 | Derived | Fang Y, Hou K, Lin D, Zhou D, Pan W, Ge J. Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders. BMC Cardiovasc Disord. 2024 Dec 30;24(1):755. doi: 10.1186/s12872-024-04438-1. |
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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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| ASD closure with normal occluder | Device | Transcatheter closure atrial septal defect with normal occluder |
|
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |