Clinical trial NCT04034498: A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects
Official title: A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Perimembranous Ventricular Septal Defect (PmVSD) Occluder in Patients With Perimembranous Ventricular Septal Defects
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Perimembranous Ventricular Septal Defect
Lead sponsor: Occlutech International AB
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be no pre-selection of patients for enrollment in this registry. The criteria provided in the Instructions For Use should be followed. The study cohort will thus consist of consecutively enrolled patients at the discretion of the treating physician

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 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

Primary outcomes:
measure: To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
timeFrame: 1 year following implantation
measure: To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
timeFrame: 1 year following implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilians University
city: Dublin
country: Ireland
facility: Children Health Ireland
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
city: Ho Chi Minh City
country: Vietnam
facility: City Children Hospital
Study officials:
References: