Cera™ VSD Occluder Post Market Clinical Follow-up

Cardiac Children's Foundation Taiwan

Status: Completed

Conditions: Ventricular Septal Defect

Treatments: Device: Cera™ VSD occluder implantation

Study type: Observational

Funder types: Other

Identifiers

NCT05939713

LT/TS/29I-01N-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

152 participants in 1 patient group

VSD subjects

Description:

Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the Cera VSD occluder as per IFU instructions

Treatment:

Device: Cera™ VSD occluder implantation