Cera™ VSD Occluder Post Market Clinical Follow-up

Ventricular Septal Defect Clinical Trial

Official title:

A Multi-center, Single Arm, Real-World Registry Assessing the Clinical Use of the Cera™ VSD Occluder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939713
• Other study ID #: LT/TS/29I-01N-01
• Status: Recruiting
• Start date: October 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Cardiac Children's Foundation Taiwan
• Contact: Yu-Chuan Hua
• Phone: +886-223319494
• Email: ccfno1[@]ms3.hinet.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Septal Defects, Ventricular
• Ventricular Septal Defect

Intervention

Device:
• Cera™ VSD occluder implantation
To collect data from patients who have implanted with the device before 2022.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Mackay Memorial Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Linkou Chang-Gung Memorial Hospita	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Cardiac Children's Foundation Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Defined as a composite of: 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.; 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	Incidence of moderate or large residual shunt		at procedure, 6 months and 12 months post-implantation
Secondary	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
Secondary	Incidence of new onset second-degree AV block		from attempted procedure to 24 months post-implantation
Secondary	Incidence of new onset severe aortic or tricuspid regurgitation		from attempted procedure to 24 months post-implantation
Secondary	Incidence of device-related thrombosis (DRT)		from attempted procedure to 24 months post-implantation
Secondary	Incidence of device embolization		from attempted procedure to 24 months post-implantation
Secondary	Incidence of device or procedure related Adverse Events (AEs)		from attempted procedure to 24 months post-implantation
Secondary	Incidence of device or procedure related Serious Adverse Events (SAEs)		from attempted procedure to 24 months post-implantation
Secondary	Incidence of Device Deficiencies (DD)		from attempted procedure to 24 months post-implantation
Secondary	Incidence of death		from attempted procedure to 24 months post-implantation