Clinical trial NCT04417712: Lifetech KONAR MFO Post-Market Clinical Follow-Up Study
Official title: Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Septal Defect
Keywords: VSD
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ventricular septal defect (VSD).

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Accurate success rate
timeFrame: From implant attempt to 12-month post-procedure.
measure: Procedure successful
timeFrame: From implant attempt to 12-month post-procedure.
Secondary outcomes:
measure: Rate of device and procedure-related serious adverse events (SAE).
timeFrame: From implant attempt to 12-month post-procedure.
measure: Rate of complete atrioventricular block (cAVB) or any arrhythmia needed for pacemaker implantation, device removal, or any kind of medical treatment.
timeFrame: From implant attempt to 12-month post-procedure.
measure: Rate of incomplete closure at the 12-month follow-up.
timeFrame: At 12-month follow-up.
measure: Rate of device deficiencies.
timeFrame: From implant attempt to 12-month post-procedure.
measure: Incidence within 12 months post-implantation
timeFrame: From implant attempt to 12-month post-procedure.
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: 103 - Herz- und Diabeteszentrum NRW / Heart and Diabetes Center NRW
city: Berlin
country: Germany
facility: 101 - Deutsches Herzzentrum der Charité/ German Heart Institute Berlin
city: Munich
country: Germany
facility: 102 - Deutsches Herzzentrum München/ German Heartcenter Munich
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
Study officials:
affiliation: Heart- and Diabetescenter NRW
name: Stephan Schubert
role: PRINCIPAL_INVESTIGATOR
References: