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

Recruitingn/aAges 3 Months - 80 YearsAllOcclutech International AB
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. * 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 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
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What it tests

  • Occlutech muscular ventricular septal defect (mVSD) Occluder
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Where

6 sites
Children's Health Ireland
Dublin, Ireland
İzmir Şehir Hastanesi
Izmir, Turkey (Türkiye)
Eskişehir Osmangazi Üniversite Hastanesi
Eskişehir, Turkey (Türkiye)
Dicle Üniversitesi Tıp Fakültesi Hastanesi
Diyarbakır, Turkey (Türkiye)
Gaziantep Unıversıty Hospital
Gaziantep, Turkey (Türkiye)
Royal Brompton Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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