Lifetech KONAR MFO Post-Market Clinical Follow-Up Study

LifeTech Scientific

Status: Completed

Conditions: Ventricular Septal Defect

Treatments: Device: KONAR-MF™ VSD Occluder

Study type: Observational

Funder types: Industry

Identifiers

NCT04417712

LT/TS/45CE-04-01

Details and patient eligibility

About

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).

Full 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 with ventricular septal defect. The implantation should be performed in accordance with the instructions for use (IFU).

Enrollment: 40 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. The patient should be older than 6 months of age and a bodyweight heavier than 8kg.
3. Defect diameter (by 2D Echocardiography): The size of the VSD is larger than or equal to 2mm and less than 10mm.
4. 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.
5. Only left to right shunt of the ventricular shunt.

Exclusion criteria

1. Any contraindication mentioned in the corresponding IFU*.

   • Note: In IFU, contraindications for The KONAR-MFTM VSD Occluder are as follows:

     1. Patient has extensive congenital cardinal anomaly which can only be adequately repaired by cardiac surgery.
     2. 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.
     3. Active endocarditis or other infections-producing bacteria.
     4. The implant of KONAR-MFTM VSD Occluder would cause an obvious interference with the aortic valve or the atrioventricular valve.
     5. Patients with severely increased pulmonary vascular resistance and a right-to-left shunt and patients with documented irreversible pulmonary vascular disease.
     6. Patients with contraindications to anti-platelet therapy or agents.

2. The patient does present with an aortic valve prolapsing into the VSD.

3. Currently participating in other investigational drugs- or device studies.

4. The patient who is pregnant, planning to become pregnant, or breastfeeding.

5. Patients don't give informed written consent for the procedure.

6. Patient with other cardiac anomalies by surgery therapy.

Trial design

40 participants in 1 patient group

Patients with ventricular septal defect

Description:

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 standards 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

Treatment:

Device: KONAR-MF™ VSD Occluder