Ventricular Septal DefectNCT05939713
Cera™ VSD Occluder Post Market Clinical Follow-up
An observational study of Ventricular Septal Defect, run by Cardiac Children's Foundation Taiwan at 8 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Ventricular Septal Defect
- What is being tested?
- Cera™ VSD occluder implantation
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 8 sitesTaiwan
- Study dates
- 13 Oct 2023to 4 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study intends to collect data from patients who have implanted with the device before 2022
Who may be able to join
- Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions
Who cannot join
- Patients did not conduct any follow up visit after hospital discharge.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Mackay Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Linkou Chang-Gung Memorial Hospita
Taoyuan
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventricular Septal Defect
- Being tested
- Cera™ VSD occluder implantation
- Keywords
- Cera VSD occluder, Observational, Retrospective, Multi-center
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cera™ VSD occluder implantationDevice
To collect data from patients who have implanted with the device before 2022.
| Study group | Role | What they receive |
|---|---|---|
| VSD subjects | Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the Cera VSD occluder as per IFU instructions Receives: Device: Cera™ VSD occluder implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 months post-implantation
Secondary outcomes (10)
Incidence of moderate or large residual shunt
Measured: 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);
Measured: from attempted procedure to 24 months post-implantation
Incidence of new onset second-degree AV block
Measured: from attempted procedure to 24 months post-implantation
Incidence of new onset severe aortic or tricuspid regurgitation
Measured: from attempted procedure to 24 months post-implantation
Incidence of device-related thrombosis (DRT)
Measured: from attempted procedure to 24 months post-implantation
Incidence of device embolization
Measured: from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Measured: from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Measured: from attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Measured: from attempted procedure to 24 months post-implantation
Incidence of death
Measured: from attempted procedure to 24 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start13 Oct 2023
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiac Children's Foundation Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jou-Kou Wang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939713
- Sponsor's protocol ID
- LT/TS/29I-01N-01
- Status last verified
- Jun 2025
- First submitted
- 3 Jul 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single Arm, Real-World Registry Assessing the Clinical Use of the Cera™ VSD Occluder
- ClinicalTrials.gov ID
- NCT05939713
- Acronym / sponsor ID
- LT/TS/29I-01N-01
- Conditions
- Ventricular Septal Defect
- Keywords
- Cera VSD occluder, Observational, Retrospective, Multi-center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Cardiac Children's Foundation TaiwanUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSD subjects | – | Device: Cera™ VSD occluder implantationPatients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the Cera VSD occluder as per IFU instructions |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study intends to collect data from patients who have implanted with the device before 2022
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions
Key exclusion criteria (1 listed)
- Patients did not conduct any follow up visit after hospital discharge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cera™ VSD occluder implantationTo collect data from patients who have implanted with the device before 2022. | Device | VSD subjects |
Primary outcome
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 .
10 secondary outcomes
Incidence of moderate or large residual shunt
Time frame: 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
Incidence of new onset second-degree AV block
Time frame: 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
Incidence of device-related thrombosis (DRT)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of device embolization
Time frame: from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time frame: 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
Incidence of Device Deficiencies (DD)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of death
Time frame: from attempted procedure to 24 months post-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jou-Kou Wang principal investigator
National Taiwan University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Septal Defect, run by Cardiac Children's Foundation Taiwan at 8 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 6 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.