The purpose of the study is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with ventricular septal defect (VSD).
This is a non-randomized prospective post-marketing clinical follow-up study (PMCFS) in order to evaluate the feasibility and safety of the Lifetech KONAR-MF™ VSD Occluder device used for patients with ventricular septal defect. The implantation should be performed in accordance with the instructions for use (IFU).
Study Type
OBSERVATIONAL
Enrollment
40
All patients will be implanted with a KONAR-MF™ VSD Occluder in accordance with the instructions for use (IFU).
103 - Herz- und Diabeteszentrum NRW / Heart and Diabetes Center NRW
Bad Oeynhausen, Germany
101 - Deutsches Herzzentrum der Charité/ German Heart Institute Berlin
Berlin, Germany
102 - Deutsches Herzzentrum München/ German Heartcenter Munich
Munich, Germany
IRCCS Policlinico San Donato
Milan, Italy
Accurate success rate
VSD closure without complication (dislocation, hemolysis, AVB, device-related valve dysfunction, thrombosis, infection, or endocarditis) and no or only mild residual shunt after 12 months of follow-up.
Time frame: From implant attempt to 12-month post-procedure.
Procedure successful
The optimal position of the VSD with appropriate closure rate at echocardiographic examination. No or only tiny or without residual shunt and absence of device-related aortic or atrioventricular valve reflux.
Time frame: From implant attempt to 12-month post-procedure.
Rate of device and procedure-related serious adverse events (SAE).
Rate of device and procedure-related serious adverse events (SAE) during 12 months post-procedure.
Time frame: From implant attempt to 12-month post-procedure.
Rate of complete atrioventricular block (cAVB) or any arrhythmia needed for pacemaker implantation, device removal, or any kind of medical treatment.
Rate of complete atrioventricular block (cAVB) or any arrhythmia needed for pacemaker implantation, device removal, or any kind of medical treatment in patients within 12 months post-implantation.
Time frame: From implant attempt to 12-month post-procedure.
Rate of incomplete closure at the 12-month follow-up.
Rate of incomplete closure at the 12-month follow-up: significant shunt will be defined as ≥ moderate or indicating treatment (surgical or interventional). The residual shunt will be defined by color Doppler echocardiography and will measure the shunt size according to prior published classification.
Time frame: At 12-month follow-up.
Rate of device deficiencies.
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Rate of device deficiencies (including device malfunction, failures, and non-conformances) during 12 months post-procedure.
Time frame: From implant attempt to 12-month post-procedure.
Incidence within 12 months post-implantation
Incidence within 12 months post-implantation for: 1. Hemolysis including any drop in hemoglobin (Hb) of \>2.5 g/dl within 24 hours and Severe acute hemolysis, which is defined as Hb ≤5 g/dl or received blood transfusion according to the clinical judgment of the study physician. Hemolysis can be excluded by sample urine within 24 hours post-implantation. If hemolysis might be suspected, blood sampling (blood count incl. hemoglobin) should be initiated according to SOP or clinical practice. 2. Thromboembolism: thrombosis of device or vascular access that requires thrombolytic therapy; 3. Migration of the occlude requiring device removal; 4. Embolization of the occluder requiring device removal.
Time frame: From implant attempt to 12-month post-procedure.