Cera™ VSD Occluder Post Market Clinical Follow-up

Cardiac Children's Foundation Taiwan152 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Ventricular Septal Defect

Interventions

Cera™ VSD occluder implantationDEVICE

To collect data from patients who have implanted with the device before 2022.

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

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.

Locations (8)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Outcomes

Primary Outcomes

Procedural success

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 .

Time frame: 6 months post-implantation

Secondary Outcomes

Incidence of moderate or large residual shunt

Time frame: at procedure, 6 months and 12 months post-implantation

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);