Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases

Study Overview
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Brief Summary
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The Occlutech® mVSD is indicated for percutaneous, transcatheter muscular ventricular septal defect closure device designed for the occlusion of hemodynamically 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.

Detailed Description
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This is a multicenter, International, follow-up registry to monitor the efficacy and safety of the Occlutech® mVSD in patients with muscular ventricular septal defects. Efficacy and safety of implanted device(s) will be assessed by vital signs, laboratory test, ECGs, and echocardiography on Day 1 (within 36 hrs. post procedure), Day 30, day 60, 6 months and 1 year after the implantation. Patients will be treated according to the instruction-for-use of the device and according to clinical routine 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. Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedure will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transseptal puncture, anterograde, retrograde or transapical device delivery approaches. Registry will be open for the next two years or when up to 100 patients are enrolled (whatever comes first) The primary efficacy endpoints will include data obtained 1 year after mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as Reduction in muscular ventricular septal regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions. The primary safety endpoint is defined as absence of Serious Adverse Events (SAEs) 1 years after mVSD closure procedure.

Official Title
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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

Conditions
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Muscular Ventricular Septal Defect

Intervention / Treatment
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* Device: muscular ventricular septal defects


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. Thus, the Occlutech® mVSD is indicated percutaneous, transcatheter muscular ventricular septal defect closure and who are deemed at high risk for surgical intervention after consultation with surgical physicians or as an alternative to surgery with less operational time and recovery period. Exclusion Criteria: The device is contraindicated for patients known to have any of the following: An aortic rim of less than 2 mm Patients weighing less than 5.0 kg Sepsis (local or generalized) Perimembranous VSD or post-MI VSD Recent myocardial infarction or a surgical bypass operation in the last 30 days 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 Allergy to anti-platelet or anticoagulant therapy Allergy to nickel and/or titanium and/or nickel/titanium-based materials Intolerance to contrast agents Active bacterial infection

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| muscular ventricular septal defects<br>patients with muscular ventricular septal defects | Device: muscular ventricular septal defects<br>* intervention cardiology and structural heart disease, including transseptal puncture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary safety endpoint | Tis defined as the absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke (an ischemic stroke that occurs within 24 hours following implantation), systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, 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. | 1 year | 
| The primary efficacy endpoint | is defined as successful implantation of the device with a proper closure of the mVSD (defined as the reduction in VSD shunt to trivial or no shunt at all, as assessed by TTE post-implantation). Efficacy assessments refer to the variation in the data from baseline to one year after the procedure in parameters such as, but not limited to, residual VSD flow/left ventricular (LV) dimensions/ left ventricular ejection fraction (LVEF)/ estimated pulmonary artery pressure demonstrated by TTE. Further efficacy assessment will be performed in the three years and the five years after implantation. | 1 year |