Assessing the safety and performance of the Cera VSD occluder
A Multi-center, Single Arm, Real-World Registry Assessing the Clinical Use of the Cera™ VSD Occluder
This study is testing how safe and effective the Lifetech Cera™ VSD occluder is for people with a Ventricular Septal Defect who got the device before 2022.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Cardiac Children's Foundation Taiwan Academic / other |
| Locations | 8 sites (Kaohsiung and 7 other locations) |
| Trial ID | NCT05939713 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of the Lifetech Cera™ VSD occluder in patients diagnosed with Ventricular Septal Defect (VSD) who received the device before 2022. Data will be collected from multiple centers to provide insights into real-world outcomes and adherence to on-label usage. The study is expected to conclude by the end of 2024, focusing on patients who have undergone follow-up visits post-implantation.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of VSD who have received the Cera VSD occluder and have attended follow-up visits.
Not a fit: Patients who did not have any follow-up visits after hospital discharge may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the Cera VSD occluder's long-term safety and performance, potentially improving patient outcomes.
How similar studies have performed: Other studies assessing similar devices have shown promising results, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kaohsiung and 7 other locations
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung, Taiwan (Not_yet_recruiting)
- Kaohsiung Veterans General Hospital — Kaohsiung, Taiwan (Not_yet_recruiting)
- Taichung Veterans General Hospital — Taichung, Taiwan (Not_yet_recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Not_yet_recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Taipei Mackay Memorial Hospital — Taipei, Taiwan (Not_yet_recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan (Not_yet_recruiting)
- Linkou Chang-Gung Memorial Hospita — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Jou-Kou Wang — National Taiwan University Hospital
- Study coordinator: Yu-Chuan Hua
- Email: ccfno1@ms3.hinet.net
- Phone: +886-223319494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.