Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
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
Occlutech International AB
50 participants
Mar 3, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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.
- Any age
- 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 Criteria15
- 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
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Interventions
Percutaneous, transcatheter (catheter-based) non-surgical closure of a muscular ventricular septal defect (mVSD) using the Occlutech mVSD Occluder. The device is a self-expandable nitinol wire-mesh occluder with two retention discs connected by a flexible waist and incorporates polyester/PET patches to support defect occlusion and tissue ingrowth. Implantation is performed by experienced operators in a specialized cath lab according to the IFU and local routine; device sizing/selection is guided by imaging (e.g., transthoracic echocardiography, angiography, fluoroscopy). The system is deployed using compatible Occlutech delivery accessories (e.g., Occlutech Pistol Pusher and Occlutech Delivery Set \[ODS v1 or ODS III\], as applicable).
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05329350