A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects

Launched by OCCLUTECH INTERNATIONAL AB · Jul 25, 2019

Keywords

ClinConnect Summary

This clinical trial is focused on studying the Occlutech® PmVSD Occluder, a device used to treat a specific heart condition known as perimembranous ventricular septal defect (VSD). This condition involves a hole in the wall that separates the heart's chambers, which can affect blood flow. The trial aims to gather more information about how effective and safe this device is for patients who have significant defects that need to be closed.

To participate in the study, patients must have a significant perimembranous VSD, meaning the hole is large enough to cause health issues. However, some patients may not be eligible, such as those with very small heart defects, certain infections, or other serious health conditions. Participants in the trial can expect to be monitored closely as researchers assess the performance of the Occluder. It’s important to note that the trial is currently active but not recruiting new patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum
• Exclusion Criteria:
• Occlutech® PmVSD Occluder is contraindicated for the following:
• • Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves
• • Patients less than 10.0 kg
• • Patients with sepsis (local or generalized)
• • Patients with left ventricle to right atrial shunting
• • Patients with right to left shunting through the defect
• • Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device
• • Patients with complex heart lesions such as tetralogy of fallot
• • History of repeated pulmonary infection
• • Any type of serious infection 1 month prior to procedure
• • Malignancy where life expectancy is less than 3 years
• • Demonstrated intracardiac thrombi on echocardiography
• • Patients with allergy to anti-platelet or anticoagulant therapy
• • Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials
• • Patients with intolerance to contrast agents
• • Patients with active bacterial infections
• • Patients with very small vessels which are not suitable for recommended delivery sheath sizes