Status:
ACTIVE_NOT_RECRUITING
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects
Lead Sponsor:
Occlutech International AB
Conditions:
Perimembranous Ventricular Septal Defect
Eligibility:
All Genders
Brief Summary
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Eligibility Criteria
Inclusion
- Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum
Exclusion
- 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
Key Trial Info
Start Date :
July 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04034498
Start Date
July 7 2019
End Date
July 1 2026
Last Update
February 15 2024
Active Locations (5)
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1
Ludwig Maximilians University
Munich, Germany
2
Children Health Ireland
Dublin, Ireland
3
Queen Sirikit National Institute of Child Health
Bangkok, Thailand
4
Prince of Songkla University
Hat Yai, Thailand