CompletedNot Applicable

Lifetech KONAR MFO Post-Market Clinical Follow-Up Study

Germany, Italy40 participantsStarted 2019-12-04

Plain-language 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).

Who can participate

Age range6 Months

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Any contraindication mentioned in the corresponding IFU\*.
✕. 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.

What they're measuring

Accurate success rate

Timeframe: From implant attempt to 12-month post-procedure.

Procedure successful

Timeframe: From implant attempt to 12-month post-procedure.

Trial details

NCT IDNCT04417712

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-30

View on ClinicalTrials.gov More Ventricular Septal Defect trials