Lifetech KONAR MFO Post-Market Clinical Follow-Up Study

Ventricular Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417712
• Other study ID #: LT/TS/45CE-04-01
• Status: Completed
• Start date: December 4, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

1. 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.

2. The patient should be older than 6 months of age and a bodyweight heavier than 8kg.

3. Defect diameter (by 2D Echocardiography): The size of the VSD is larger than or equal to 2mm and less than 10mm.

4. 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.

5. Only left to right shunt of the ventricular shunt.

Exclusion Criteria:

1. Any contraindication mentioned in the corresponding IFU*.

• Note: In IFU, contraindications for The KONAR-MFTM VSD Occluder are as follows:

1. Patient has extensive congenital cardinal anomaly which can only be adequately repaired by cardiac surgery.

2. 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.

3. Active endocarditis or other infections-producing bacteria.

4. The implant of KONAR-MFTM VSD Occluder would cause an obvious interference with the aortic valve or the atrioventricular valve.

5. Patients with severely increased pulmonary vascular resistance and a right-to-left shunt and patients with documented irreversible pulmonary vascular disease.

6. Patients with contraindications to anti-platelet therapy or agents.

2. The patient does present with an aortic valve prolapsing into the VSD.

3. Currently participating in other investigational drugs- or device studies.

4. The patient who is pregnant, planning to become pregnant, or breastfeeding.

5. Patients don't give informed written consent for the procedure.

6. Patient with other cardiac anomalies by surgery therapy.

Related Conditions & MeSH terms

• Heart Septal Defects, Ventricular
• Ventricular Septal Defect

Intervention

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

Locations

Country	Name	City	State
Germany	103 - Herz- und Diabeteszentrum NRW / Heart and Diabetes Center NRW	Bad Oeynhausen
Germany	101 - Deutsches Herzzentrum der Charité/ German Heart Institute Berlin	Berlin
Germany	102 - Deutsches Herzzentrum München/ German Heartcenter Munich	Munich
Italy	IRCCS Policlinico San Donato	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	From implant attempt to 12-month post-procedure.
Secondary	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.	From implant attempt to 12-month post-procedure.
Secondary	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.	At 12-month follow-up.
Secondary	Rate of device deficiencies.	Rate of device deficiencies (including device malfunction, failures, and non-conformances) during 12 months post-procedure.	From implant attempt to 12-month post-procedure.
Secondary	Incidence within 12 months post-implantation	Incidence within 12 months post-implantation for: 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.; Thromboembolism: thrombosis of device or vascular access that requires thrombolytic therapy; Migration of the occlude requiring device removal; Embolization of the occluder requiring device removal.	From implant attempt to 12-month post-procedure.