Monitoring the effectiveness and safety of the Occlutech mVSD device for heart defects
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
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 3 Months to 80 Years |
| Sex | All |
| Sponsor | Occlutech International AB Industry-sponsored |
| Locations | 5 sites (Dublin and 4 other locations) |
| Trial ID | NCT05329350 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with muscular ventricular septal defects who are at high risk for surgical intervention.
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.
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 performed: Other studies have shown success with similar transcatheter closure approaches, indicating a promising avenue for treatment.
Eligibility criteria
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 this trial is running
Dublin and 4 other locations
- 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)
- Gaziantep Unıversıty Hospital — Gaziantep, Şehitkamil, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ahmed Della
- Email: ahmed.dellaa@occlutech.com
- Phone: +49 151 14139961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.