Status:
COMPLETED
Lifetech KONAR MFO Post-Market Clinical Follow-Up Study
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Ventricular Septal Defect
Eligibility:
All Genders
6+ years
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 sept...
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- Patients have a clinically relevant ventricular septum defect (VSD) by Echocardiography and/or X-ray examination according to current clinical standards and center-specific protocols.
- The patient should be older than 6 months of age and a bodyweight heavier than 8kg.
- Defect diameter (by 2D Echocardiography): The 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
- Any contraindication mentioned in the corresponding IFU\*.
- Note: In IFU, contraindications for The KONAR-MFTM VSD Occluder are as follows:
- Patient has extensive congenital cardinal anomaly which can only be adequately repaired by cardiac surgery.
- Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained.
- Active endocarditis or other infections-producing bacteria.
- The implant of KONAR-MFTM VSD Occluder would cause an obvious interference with the aortic valve or the atrioventricular valve.
- Patients with severely increased pulmonary vascular resistance and a right-to-left shunt and patients with documented irreversible pulmonary vascular disease.
- Patients with contraindications to anti-platelet therapy or agents.
- 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.
Key Trial Info
Start Date :
December 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04417712
Start Date
December 4 2019
End Date
June 30 2023
Last Update
April 15 2024
Active Locations (4)
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1
103 - Herz- und Diabeteszentrum NRW / Heart and Diabetes Center NRW
Bad Oeynhausen, Germany, 32545
2
101 - Deutsches Herzzentrum der Charité/ German Heart Institute Berlin
Berlin, Germany, 13353
3
102 - Deutsches Herzzentrum München/ German Heartcenter Munich
Munich, Germany, 80636
4
IRCCS Policlinico San Donato
Milan, Italy, 20097