A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Perimembranous Ventricular Septal Defect (PmVSD) Occluder in Patients With Perimembranous Ventricular Septal Defects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
研究概览
简要总结
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum
排除标准
- •Occlutech® PmVSD Occluder is contraindicated for the following:
- •Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves
- •Patients less than 10.0 kg
- •Patients with sepsis (local or generalized)
- •Patients with left ventricle to right atrial shunting
- •Patients with right to left shunting through the defect
- •Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device
- •Patients with complex heart lesions such as tetralogy of fallot
- •History of repeated pulmonary infection
- •Any type of serious infection 1 month prior to procedure
- •Malignancy where life expectancy is less than 3 years
- •Demonstrated intracardiac thrombi on echocardiography
- •Patients with allergy to anti-platelet or anticoagulant therapy
- •Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials
- •Patients with intolerance to contrast agents
- •Patients with active bacterial infections
- •Patients with very small vessels which are not suitable for recommended delivery sheath sizes
结局指标
主要结局
To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
时间窗: 1 year following implantation
The primary safety endpoint is defined as absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, new-onset of severe tricuspid regurgitation (TR), new onset of severe aortic regurgitation (AR), device embolization, severe right-left ventricular outflow obstruction (RVOTO-LVOTO), cardiac tamponade, infective endocarditis or vascular complications requiring surgery.
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
时间窗: 1 year following implantation
The primary efficacy endpoint is defined as successful implantation of the device with a proper closure of the pmVSD (defined as reduction in VSD shunt of more than one grade as assessed by TTE post implantation).
次要结局
未报告次要终点