Monitoring the effectiveness and safety of the Occlutech mVSD device for heart defects
Official title: 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
Run by Occlutech International AB · NCT05329350 · Data updated 2026-11-12
This study is testing whether the Occlutech mVSD device can safely and effectively close heart defects in patients who are not good candidates for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Months to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Occlutech International AB Industry-sponsored |
| Locations | 6 sites (Dublin and 5 other locations) |
| Status | Recruiting |
| Started | March 3, 2022 |
| Main results expected | January 1, 2031 |
| Study ends | June 1, 2031 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT05329350 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with muscular ventricular septal defects who are at high risk for surgical intervention.
✕Probably not a fit
Patients with contraindications such as an aortic rim of less than 2 mm or those weighing less than 5.0 kg may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the efficacy and safety of the Occlutech® mVSD device, which is used for the transcatheter closure of muscular ventricular septal defects in patients at high risk for surgical intervention. The study will involve a multicenter, international follow-up registry that will monitor patients over a period of one year after the device implantation. Efficacy will be assessed through various clinical evaluations, including vital signs, laboratory tests, ECGs, and echocardiography at multiple time points post-procedure. The registry will enroll up to 100 patients or remain open for two years, whichever comes first.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with muscular ventricular septal defects, potentially improving recovery times and outcomes.
How similar studies have gone: Other studies have shown success with similar transcatheter closure approaches, indicating a promising avenue for treatment.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Gaziantep Unıversıty Hospital
Gaziantep, Şehitkamil, Turkey (Türkiye) Recruiting -
Children's Health Ireland
Dublin, Ireland Not yet recruiting -
İzmir Şehir Hastanesi
Izmir, Bayraklı, Turkey (Türkiye) Not yet recruiting -
Eskişehir Osmangazi Üniversite Hastanesi
Eskişehir, Odunpazarı, Turkey (Türkiye) Not yet recruiting -
Dicle Üniversitesi Tıp Fakültesi Hastanesi
Diyarbakır, Sur, Turkey (Türkiye) Not yet recruiting -
Royal Brompton Hospital
London, England, United Kingdom Not yet recruiting
Study contacts
- Study coordinator: Ahmed Dellaa
- Email: ahmed.dellaa@occlutech.com
- Phone: +49 151 14139961
Similar studies
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Registry for Abbott's heart devices
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Transcatheter closure of perimembranous heart defects across centers
This registry tests how well transcatheter closure devices work for perimembranous ventricular septal defects in kids and adults across several international centers.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.