An interventional study of ASD closure with the novel occluder (ReAces) and ASD closure with normal occluder in Atrial Septal Defect, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's planned enrollment of 128 is above the median of 72 across 51 interventional studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with ASD assigned to experimental group will receive the novel ASD occluder (ReAces)
Device: ASD closure with the novel occluder (ReAces)
Patients with ASD assigned to control group will receive the normal occluder
Device: ASD closure with normal occluder
Transcatheter closure atrial septal defect with the novel occluder (ReAces)
Transcatheter closure atrial septal defect with normal occluder
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.
Time frame: 0-360 days
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.
Time frame: 0-360 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital