Lifetech MFO Post-Market Clinical Follow-Up Study
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a non-randomized prospective post-marketing clinical follow-up study (PMCFS) in order to evaluate the feasibility and safety of Lifetech KONAR-MF™ VSD Occluder device used for patients with ventricular septal defect. The implantation should be performed in accordance to the instructions for use (IFU).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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).
|
Outcome Measures
Primary Outcome Measures
- Accurate success rate [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients have a clinically relevant ventricular septum defect (VSD) by echocardiography and/or X-ray examination according to current clinical standard and centre-specific protocols.
The patient should be older than 6 months of age and the bodyweight heavier than 8kg.
Defect diameter (by 2D echocardiography): Size of the VSD is larger than or equal to 2mm and less than 10mm.
Upper margin of VSD to aortic valve distance >2 mm for models 6-4, 8-6, 10-8, 12-10, 14-12 and >2.5mm for models 5-3, 7-5, 9-7, in case of PmVSD.
Only left to right shunt of the ventricular shunt.
Exclusion Criteria:
Any contraindication mentioned in the corresponding IFU*.
The patient does present with an aortic valve prolapsing into the VSD.
Currently participating in other investigational drugs- or device studies.
The patient who is pregnant, planning to become pregnant, or breastfeeding.
Patients don't give informed written consent for the procedure.
Patient with other cardiac anomalies by surgery therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart- and Diabetescenter NRW | Bad Oeynhausen | Germany | ||
| 2 | Deutsches Herzzentrum Berlin | Berlin | Germany | ||
| 3 | Deutsches Herzzentrum München | Munich | Germany | ||
| 4 | IRCCS Policlinico San Donato | Milan | Italy |
Sponsors and Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
- Principal Investigator: Stephan Schubert, Heart- and Diabetescenter NRW
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LT/TS/45CE-04-01