Cera™ VSD Occluder Post Market Clinical Follow-up

Recruiting

• Conditions: Ventricular Septal Defect
• Interventions: Device: Cera™ VSD occluder implantation

• Registration Number: NCT05939713
• Lead Sponsor: Cardiac Children's Foundation Taiwan

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.

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Study Start: 2023-10-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VSD subjects	Cera™ VSD occluder implantation	Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the Cera VSD occluder as per IFU instructions

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of new onset second-degree AV block	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 new onset severe aortic or tricuspid regurgitation	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 death	from attempted procedure to 24 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 device-related thrombosis (DRT)	from attempted procedure to 24 months post-implantation
Incidence of device embolization	from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)	from attempted procedure to 24 months post-implantation

Trial Locations

Locations (8)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Linkou Chang-Gung Memorial Hospita; 🇨🇳 Taoyuan, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Taipei Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan