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

Occlutech

Status: Active, not recruiting

Conditions: Perimembranous Ventricular Septal Defect

Study type: Observational

Funder types: Industry

Identifiers

NCT04034498

Occ2018-01

Details and patient eligibility

About

The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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