Lifetech MFO Post-Market Clinical Follow-Up Study

Related Clinical Trial
The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters Improving Care for Children With Congenital Heart Disease. Lifetech MFO Post-Market Clinical Follow-Up Study Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics Optical Tissue Identification for Myocardial Architecture Measures to Lower the Stress Response in Pediatric Cardiac Surgery Cardiac Function After Transcatheter VSD Closure The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder – Post Approval Study The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects. Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol Optimal Timing for Repair of Left to Right Shunt Lesions Use of Ketamine Prior to Cardiopulmonary Bypass in Children Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect Longterm Outcome After Ventricular Septal Defect Closure Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER Hybrid Closure of Congenital Heart Disease

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


Primary Outcome

Accurate success rate


Ventricular Septal Defect


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


* 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


Estimated Enrollment


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

        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.




6 Months - N/A

Accepts Healthy Volunteers



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

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Study Sponsor

Stephan Schubert, Principal Investigator, Heart- and Diabetescenter NRW

Verification Date

May 2021