| 标题 |
A prospective, multicenter, randomized controlled trial to verify the safety and efficacy of a nano-membrane single riveted ventricular septal defect (VSD) occluder in clinical practice
一项验证纳米膜单铆接室间隔缺损(VSD)封堵器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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| 其它 | INTERVENTION: Group A:nano membrane single riveted ventricular septal defect (VSD) occluder;Group B:ventricular septal defect (VSD) occluder; CONDITION: Ventricular septal defect PRIMARY OUTCOME: blocking success rate; SECONDARY OUTCOME: technique success rate; INCLUSION CRITERIA: 1. Aged 1 to 60 years old, weight more than 5 kg, male or non‐pregnant women; 2. Membranous ventricular septal defect with hemodynamic abnormalities or increased left ventricular diamete 3. The narrowest part of ventricular septal defect (VSD) 3mm to 12mm; 4. The upper margin of the ventricular septal defect is >=2mm from the right aortic valve and >=2mm from the tricuspid septal valve. There is no aortic right coronary valve detachment into the ventricular septal defect and aortic valve reflux; 5. Ultrasound at 9‐12 o'clock on the short‐axis five‐chamber view of the large vessel; 6. Understand the purpose of the trial, volunteer to participate in the trial and sign the "Informed Consent form". |
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