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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Occlutech International AB
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Months to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
muscular ventricular septal defects
patients with muscular ventricular septal defects
Intervention: Occlutech muscular ventricular septal defect (mVSD) Occluder (Device)
Outcomes
Primary Outcomes
Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)