Cera™ VSD Occluder Post Market Clinical Follow-up

NCT05939713 | Completed

• 1 other identifier: LT/TS/29I-01N-01
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 8

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.

Conditions

Ventricular Septal Defect

Keywords

Cera VSD occluder; Observational; Retrospective; Multi-center

Outcome Measures

Primary Outcomes (1)

• 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 .

  6 months post-implantation

Secondary Outcomes (10)

• Incidence of moderate or large residual shunt

  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);

  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

Study Arms (1)

VSD subjects

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

Device: Cera™ VSD occluder implantation

Interventions

Cera™ VSD occluder implantation DEVICE

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

VSD subjects

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study intends to collect data from patients who have implanted with the device before 2022

You may qualify if:

• Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions

You may not qualify if:

• Patients did not conduct any follow up visit after hospital discharge.

Sponsors & Collaborators

• Cardiac Children's Foundation Taiwan: lead

Study Sites (8)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Mackay Memorial Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Linkou Chang-Gung Memorial Hospita

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jou-Kou Wang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: October 13, 2023
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (8)