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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Septal Defect
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Successful rate of complete closure of atrial septal defect
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Junbo Ge
Principal Investigator
Shanghai Zhongshan Hospital
Eligibility Criteria
Inclusion Criteria
- •aged 18-70 years;
- •with congenital secundum atrial septal defect;
- •the maximal ASD diameter was ≤38 mm;
- •with atrial-level left-to-right shunt, with Qp/Qs shunt ratio ≥1.5:1, or TTE or clinical manifestations indicated the existence of defect that inducing overfilling of right atrium;
- •the distance from the margin of defect to coronary sinus, atrioventricular (AV) valve, and right superior pulmonary vein (RSPV) was ≥5 mm, according to the echocardiography measurements;
- •volunteered to participate in this study, and signed informed consents.
Exclusion Criteria
- •ostium primordium ASD and sinus venosus ASD.
- •infective endocarditis and hemorrhagic disorders.
- •active thrombosis.
- •patients with severe pulmonary hypertension (mean pulmonary artery pressure measured by catheter \> 30 mmHg) who are not taking targeted drugs
- •patients with a porous atrial septal defect that cannot be completely occluded by a single occluder.
- •with severe myocardial disorders or valvular disease not associated with ASD
- •infectious disease within the last 1 month, or uncontrolled infectious disease
- •bleeding disorders, untreated gastric or duodenal ulcers
- •thrombosis in left atrium
- •partial or total pulmonary vein ectopic drainage
Outcomes
Primary Outcomes
Successful rate of complete closure of atrial septal defect
Time Frame: 0-360 days
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.
Secondary Outcomes
- Adverse events(0-360 days)