A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation
研究概览
简要总结
The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
The objectives of the study are:
- To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
- To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
详细描述
This is a multicenter, prospective, and retrospective, international, post-market clinical follow-up Study to monitor the efficacy and safety of the Occlutech mVSD in patients with muscular ventricular septal defects.
Safety and efficacy of implanted devices are assessed by echocardiography, vital signs, laboratory tests, and ECGs on Day 1 (within 48 hours post-procedure), follow-up 1 (between Day 30 and Day 60), follow-up 2 at 6 months (from Day 61 until 6 months), follow-up 3 at 1 year (from 6 months until 1 year), and follow-up 4 at 3 years (from 1 year until 3 years).
- Patients will be screened to determine eligibility for the registry based on inclusion/exclusion criteria, through their medical history, demographics, vital signs, clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and echocardiography data.
- Participants are treated according to the instructions-for-use (IFU) of the device and according to clinical routine.
- Procedures are performed at sites having appropriate laboratory support and adequately trained imaging personnel. The procedure is performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transcatheter patent ductus arteriosus, atrial septal defect, and ventricular septal defect (VSD) closures.
Recruitment will be open until 50 Patients have been enrolled. The primary safety endpoint is defined as the incidence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, ischemic stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, new onset of severe tricuspid regurgitation (TR), new the onset of severe aortic regurgitation (AR), severe right-left ventricular outflow obstruction (RVOTO-LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open heart surgery up to 1 year after the mVSD closure procedure.
The primary efficacy endpoints will include data obtained 1 year after the mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as the reduction in muscular ventricular septal shunt to trivial or no shunt at all, as assessed by echocardiography pre- vs post-implantation).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A participant will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
- •Male or female.
- •Patients understand the nature of the study and provide their informed consent to participation.
- •Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.
- •Contraindication
- •Hemodynamically relevant VSD shunt
- •Congestive heart insufficiency
- •Recurrent respiratory infections
- •Failure to thrive.
- •Significant left ventricle (LV) enlargement
- •Significant left atrium (LA) enlargement
- •Other clinical indication
排除标准
- •The device is contraindicated for participants known to have any of the following:
- •⦁Active bacterial infections
- •Active infection at the time of implantation
- •Allergy to antiplatelet or anticoagulant therapy
- •Allergy to nickel and/or titanium and/or nickel/titanium-based materials
- •Any type of serious infection 1 month before the procedure
- •The aortic rim of less than 2 mm
- •Demonstrated intracardiac thrombi on echocardiography
- •Malignancy where life expectancy is less than 3 years
- •mVSD diameter > 20 mm
- •Perimembranous VSD
- •Post-MI VSD
- •Recent myocardial infarction or a surgical bypass operation in the last 30 days
- •Sepsis (local or generalized)
- •Septal thickness > 7 mm in the area of the Occluder placement
研究组 & 干预措施
muscular ventricular septal defects
patients with muscular ventricular septal defects
干预措施: Occlutech muscular ventricular septal defect (mVSD) Occluder (Device)
结局指标
主要结局
Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation
时间窗: Up to 12 months post-procedure
Serious Adverse Device Effects (SADEs) include procedure-related death, stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, severe tricuspid regurgitation (TR), severe aortic regurgitation (AR), right ventricular outflow tract obstruction (RVOTO), left ventricular outflow tract obstruction (LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open-heart surgery.
Percentage of Participants With Successful Device Implantation and Trivial or No Residual Ventricular Septal Shunt at 12 Months
时间窗: 12 months post-procedure
Successful implantation of the Occlutech mVSD Occluder with effective closure defined as reduction of the muscular ventricular septal shunt to trivial or no residual shunt, as assessed by echocardiography.
The primary safety endpoint
时间窗: 1 year
The primary safety endpoint is defined as the incidence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, ischemic stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, new onset of severe tricuspid regurgitation (TR), new the onset of severe aortic regurgitation (AR), severe right-left ventricular outflow obstruction (RVOTO-LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open heart surgery up to 1 year after the mVSD closure procedure.
The primary efficacy endpoint
时间窗: 1 year
The primary efficacy endpoints will include data obtained 1 year after the mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as the reduction in muscular ventricular septal shunt to trivial or no shunt at all, as assessed by echocardiography pre- vs post-implantation).
次要结局
- Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Between 1 and 3 Years After Occlutech mVSD Implantation(1 year to 3 years post-procedure)
- Percentage of Participants With Minor Complications, Including Transient Hemolysis and Non-Surgical Vascular Complications, Up to 3 Years(Up to 3 years post-procedure)