International Follow-up Study of the Occlutech Muscular Ventricular Septal Defect Occluder Monitoring Safety and Effectiveness in Patients with Muscular Ventricular Septal Defects

What this Trial Is About

Researchers are monitoring the safety and effectiveness of the Occlutech muscular ventricular septal defect mVSD Occluder in patients with muscular ventricular septal defects. This international follow-up study includes both prospective and retrospective data collection to confirm how well the device closes muscular ventricular septal defects and to assess any serious adverse effects related to its use. The study is sponsored by Occlutech International AB and aims to enroll up to 50 patients. Participants receive the Occlutech mVSD Occluder through a minimally invasive catheter-based procedure performed by experienced cardiologists in specialized facilities. The device is a self-expandable wire-mesh occluder designed to close the defect and support tissue growth. Patients are treated according to device instructions and usual clinical practice. Follow-up visits occur at intervals including within 48 hours post-procedure, 1 to 2 months, 6 months, 1 year, and up to 3 years after implantation. During the study, participants undergo echocardiography, vital signs monitoring, lab tests, and ECGs to assess device performance and safety. Researchers measure the rate of serious device-related adverse events within 12 months and successful defect closure at 1 year. Additional monitoring continues up to 3 years for minor complications and late safety outcomes. Participants are expected to attend scheduled follow-up visits and assessments throughout the study period.

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