Lifetech MFO Post-Market Clinical Follow-Up Study

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Brief Title

Lifetech MFO Post-Market Clinical Follow-Up Study

Official Title

Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study Clinical Investigation Plan

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).
    

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 Type

Observational


Primary Outcome

Accurate success rate


Condition

Ventricular Septal Defect

Intervention

KONAR-MF™ VSD Occluder

Study Arms / Comparison Groups

 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 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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

December 4, 2019

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2021

Eligibility 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.
      

Gender

All

Ages

6 Months - N/A

Accepts Healthy Volunteers

No

Contacts

Stephan Schubert, +49 5731 97 1380, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04417712

Organization ID

LT/TS/45CE-04-01


Responsible Party

Sponsor

Study Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.


Study Sponsor

Stephan Schubert, Principal Investigator, Heart- and Diabetescenter NRW


Verification Date

May 2021