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Ventricular Septal DefectNCT04417712

Lifetech KONAR MFO Post-Market Clinical Follow-Up Study

An observational study of Ventricular Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Ventricular Septal Defect
What is being tested?
KONAR-MF™ VSD Occluder
Type of treatment
Medical device
How many people
40 participants
Where
4 sitesin 2 countries
Study dates
4 Dec 2019to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with ventricular septal defect (VSD).

Who may be able to join

  • 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.
  • The patient should be older than 6 months of age and a bodyweight heavier than 8kg.
  • Defect diameter (by 2D Echocardiography): The 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.

Who cannot join

  • Any contraindication mentioned in the corresponding IFU*.
  • Note: In IFU, contraindications for The KONAR-MFTM VSD Occluder are as follows:
  • Patient has extensive congenital cardinal anomaly which can only be adequately repaired by cardiac surgery.
  • 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.
  • Active endocarditis or other infections-producing bacteria.
  • The implant of KONAR-MFTM VSD Occluder would cause an obvious interference with the aortic valve or the atrioventricular valve.
Show all 13Show fewer
  • Patients with severely increased pulmonary vascular resistance and a right-to-left shunt and patients with documented irreversible pulmonary vascular disease.
  • Patients with contraindications to anti-platelet therapy or agents.
  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Germany3 sites

  • 103 - Herz- und Diabeteszentrum NRW / Heart and Diabetes Center NRW

    Bad Oeynhausen, 32545

  • 101 - Deutsches Herzzentrum der Charité/ German Heart Institute Berlin

    Berlin, 13353

  • 102 - Deutsches Herzzentrum München/ German Heartcenter Munich

    Munich, 80636

Other trials in Germany

Italy1 site

  • IRCCS Policlinico San Donato

    Milan, 20097

Other trials in Italy

About this study

Official title: Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study

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).

Read the detailed 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).

Being tested
KONAR-MF™ VSD Occluder
Keywords
VSD
Medical subject headings
Heart Septal Defects, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KONAR-MF™ VSD OccluderDevice

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

Study groups in NCT04417712
Study groupRoleWhat they receive
Patients with ventricular septal defectAll 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
Receives: Device: KONAR-MF™ VSD Occluder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accurate success rate

    VSD closure without complication (dislocation, hemolysis, AVB, device-related valve dysfunction, thrombosis, infection, or endocarditis) and no or only mild residual shunt after 12 months of follow-up.

    Measured: From implant attempt to 12-month post-procedure.

  2. Procedure successful

    The 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 atrioventricular valve reflux.

    Measured: From implant attempt to 12-month post-procedure.

Secondary outcomes (5)

  1. Rate of device and procedure-related serious adverse events (SAE).

    Rate of device and procedure-related serious adverse events (SAE) during 12 months post-procedure.

    Measured: From implant attempt to 12-month post-procedure.

  2. Rate of complete atrioventricular block (cAVB) or any arrhythmia needed for pacemaker implantation, device removal, or any kind of medical treatment.

    Rate of complete atrioventricular block (cAVB) or any arrhythmia needed for pacemaker implantation, device removal, or any kind of medical treatment in patients within 12 months post-implantation.

    Measured: From implant attempt to 12-month post-procedure.

  3. Rate of incomplete closure at the 12-month follow-up.

    Rate of incomplete closure at the 12-month follow-up: significant shunt will be defined as ≥ moderate or indicating treatment (surgical or interventional). The residual shunt will be defined by color Doppler echocardiography and will measure the shunt size according to prior published classification.

    Measured: At 12-month follow-up.

  4. Rate of device deficiencies.

    Rate of device deficiencies (including device malfunction, failures, and non-conformances) during 12 months post-procedure.

    Measured: From implant attempt to 12-month post-procedure.

  5. Incidence within 12 months post-implantation

    Incidence within 12 months post-implantation for:

    1. Hemolysis including any drop in hemoglobin (Hb) of >2.5 g/dl within 24 hours and Severe acute hemolysis, which is defined as Hb ≤5 g/dl or received blood transfusion according to the clinical judgment of the study physician. Hemolysis can be excluded by sample urine within 24 hours post-implantation. If hemolysis might be suspected, blood sampling (blood count incl. hemoglobin) should be initiated according to SOP or clinical practice.
    2. Thromboembolism: thrombosis of device or vascular access that requires thrombolytic therapy;
    3. Migration of the occlude requiring device removal;
    4. Embolization of the occluder requiring device removal.

    Measured: From implant attempt to 12-month post-procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start4 Dec 2019
  3. Primary completion30 Mar 2022
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417712
Sponsor's protocol ID
LT/TS/45CE-04-01
Status last verified
Apr 2024
First submitted
2 Jun 2020
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accurate success rate (time frame: From implant attempt to 12-month post-procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.

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