Cera™ VSD Occluder Post Market Clinical Follow-up

November 15, 2023 updated by: Cardiac Children's Foundation Taiwan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Not yet recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung, Taiwan
        • Not yet recruiting
        • Kaohsiung Veterans General Hospital
      • Taichung, Taiwan
        • Not yet recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan
        • Not yet recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Jou-Kou Wang
      • Taipei, Taiwan
        • Not yet recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Not yet recruiting
        • Taipei Mackay Memorial Hospital
      • Taoyuan, Taiwan
        • Recruiting
        • Linkou Chang-Gung Memorial Hospita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
To collect data from patients who have implanted with the device before 2022.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: 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 .
6 months post-implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of device or procedure related Adverse Events (AEs)
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of death
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of moderate or large residual shunt
Time Frame: at procedure, 6 months and 12 months post-implantation
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);
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of new onset second-degree AV block
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of new onset severe aortic or tricuspid regurgitation
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of device-related thrombosis (DRT)
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of device embolization
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiac Children's Foundation Taiwan

Investigators

  • Principal Investigator: Jou-Kou Wang, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT/TS/29I-01N-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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