Lifetech MFO Post-Market Clinical Follow-Up Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04417712|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment|
|Ventricular Septal Defect||Device: KONAR-MF™ VSD Occluder|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study Clinical Investigation Plan|
|Actual Study Start Date :||December 4, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Patients with ventricular septal defect
All patients who signed informed consent and are implanted with a KONAR-MF™ VSD Occluder device will undergo follow-up (FU) evaluations as per local hospital standard and corresponding IFU which is expected to be at the following time points post-implant:
Before discharge 1-3 months after the Procedure 6 months after the procedure 12 months after the procedure
Device: KONAR-MF™ VSD Occluder
All patients will be implanted with a KONAR-MF™ VSD Occluder in accordance with the instructions for use (IFU).
- Accurate success rate [ Time Frame: 12 month ]VSD closure without complication (dislocation, hemolysis, AVB, device related valve dysfunction, thrombosis, infection or endocarditis) and no or only mild residual shunt.
- Procedure successful [ Time Frame: 12 month ]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 atrio ventricular valve reflux.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417712
|Contact: Stephan Schubert||+49 30 4593 2800||sschubert@DHZB.de|
|Deutsches Herzzentrum Berlin||Recruiting|
|Contact: Stephan Schubert|
|Deutsches Herzzentrum München||Recruiting|
|Contact: Peter Ewert|
|IRCCS Policlinico San Donato||Recruiting|
|Contact: Mario Carminati|
|Principal Investigator:||Stephan Schubert||German Heart Institute|