Ventricular Septal Defect
Conditions
Keywords
Cera VSD occluder, Observational, Retrospective, Multi-center
Brief summary
The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.
Detailed description
The study intends to collect data from patients who have implanted with the device before 2022. The study is expected to completed by the end of 2024.
Interventions
DEVICECera™ VSD occluder implantation
To collect data from patients who have implanted with the device before 2022.
Sponsors
Cardiac Children's Foundation Taiwan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions
Exclusion criteria
* Patients did not conduct any follow up visit after hospital discharge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 6 months post-implantation | Defined as a composite of: 1. Absence of complete atrioventricular block (third degree AV block) needing pacemaker implantation, device embolization, severe aortic regurgitation requiring surgical repair or device or procedure related death, assessed at 6 months post-implantation. 2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation . |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of new onset complete AV block (third-degree AV block) or any new onset arrhythmia needing for pacemaker implantation, or new onset left bundle branch block (LBBB); | from attempted procedure to 24 months post-implantation |
| Incidence of new onset second-degree AV block | from attempted procedure to 24 months post-implantation |
| Incidence of new onset severe aortic or tricuspid regurgitation | from attempted procedure to 24 months post-implantation |
| Incidence of device-related thrombosis (DRT) | from attempted procedure to 24 months post-implantation |
| Incidence of moderate or large residual shunt | at procedure, 6 months and 12 months post-implantation |
| Incidence of device or procedure related Adverse Events (AEs) | from attempted procedure to 24 months post-implantation |
| Incidence of device or procedure related Serious Adverse Events (SAEs) | from attempted procedure to 24 months post-implantation |
| Incidence of Device Deficiencies (DD) | from attempted procedure to 24 months post-implantation |
| Incidence of death | from attempted procedure to 24 months post-implantation |
| Incidence of device embolization | from attempted procedure to 24 months post-implantation |
Countries
Taiwan
Outcome results
None listed