Lifetech MFO Post-Market Clinical Follow-Up Study

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    40
  • sponsor
    Lifetech Scientific (Shenzhen) Co., Ltd.
Updated on 1 December 2021

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).

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).

Details
Condition Ventricular septal defect
Treatment KONAR-MF™ VSD Occluder
Clinical Study IdentifierNCT04417712
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
Last Modified on1 December 2021

Eligibility

Yes No Not Sure

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
-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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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