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Lifetech MFO Post-Market Clinical Follow-Up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417712
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

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).

Condition or disease Intervention/treatment
Ventricular Septal Defect Device: KONAR-MF™ VSD Occluder

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).

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study Clinical Investigation Plan
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with ventricular septal defect

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

Device: KONAR-MF™ VSD Occluder
All patients will be implanted with a KONAR-MF™ VSD Occluder in accordance with the instructions for use (IFU).




Primary Outcome Measures :
  1. Accurate success rate [ Time Frame: 12 month ]
    VSD closure without complication (dislocation, hemolysis, AVB, device related valve dysfunction, thrombosis, infection or endocarditis) and no or only mild residual shunt.

  2. Procedure successful [ Time Frame: 12 month ]
    Optimal position of the VSD with appropriate closure rate at echocardiographic examination. No or only tiny or without residual shunt and absence of device related aortic or atrio ventricular valve reflux.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ventricular septal defect.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417712


Contacts
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Contact: Stephan Schubert +49 30 4593 2800 sschubert@DHZB.de

Locations
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Germany
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany
Contact: Stephan Schubert         
Deutsches Herzzentrum München Recruiting
Munich, Germany
Contact: Peter Ewert         
Italy
IRCCS Policlinico San Donato Recruiting
Milan, Italy
Contact: Mario Carminati         
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
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Principal Investigator: Stephan Schubert German Heart Institute
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Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04417712    
Other Study ID Numbers: LT/TS/45CE-04-01
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Septal Defects, Ventricular
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities