| 标题 |
A prospective, multicenter, randomized controlled trial to verify the safety and efficacy of a fully degradable ventricular septal defect (VSD) closure system in clinical practice
一项验证完全可降解室间隔缺损（VSD）封堵系统在临床实践中安全性和有效性的前瞻性、多中心、随机对照试验
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| 网址 |
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| DOI |
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| 其它 | INTERVENTION: Group A:Fully degradable ventricular septal defect closure system;Group B:Ventricular septal defect occluder; CONDITION: Ventricular septal deficiency PRIMARY OUTCOME: Blocking success rate; SECONDARY OUTCOME: Surgical technique success rate; INCLUSION CRITERIA: 1. Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow‐up and related examinations as required by the follow‐up; 2. Aged 1 to 60 years old, weight more than 10 kg, male or non‐pregnant women; 3. VSD effective shunt =3mm, =14mm; 4. Distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation. |
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