Lifetech KONAR MFO Post-Market Clinical Follow-Up Study

NCT04417712 | Completed

• 1 other identifier: LT/TS/45CE-04-01
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 4

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).

Conditions

Ventricular Septal Defect

Keywords

VSD

Outcome Measures

Primary Outcomes (2)

• 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.

  From implant attempt to 12-month post-procedure.

• 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.

  From implant attempt to 12-month post-procedure.

Secondary Outcomes (5)

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

  From implant attempt to 12-month post-procedure.

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

  From implant attempt to 12-month post-procedure.

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

  At 12-month follow-up.

• Rate of device deficiencies.

  From implant attempt to 12-month post-procedure.

• Incidence within 12 months post-implantation

  From implant attempt to 12-month post-procedure.

Study Arms (1)

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 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

Device: KONAR-MF™ VSD Occluder

Interventions

KONAR-MF™ VSD Occluder DEVICE

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

Patients with ventricular septal defect

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ventricular septal defect (VSD).

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (4)

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

Bad Oeynhausen, 32545, Germany

Location

101 - Deutsches Herzzentrum der Charité/ German Heart Institute Berlin

Berlin, 13353, Germany

Location

102 - Deutsches Herzzentrum München/ German Heartcenter Munich

Munich, 80636, Germany

Location

IRCCS Policlinico San Donato

Milan, 20097, Italy

Location

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stephan Schubert

  Heart- and Diabetescenter NRW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: December 4, 2019
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

DE (3); IT (1)