Assessment of Lifetech CeraFlex™ Device for Atrial Septal Defect
A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
This study looks at how well the Lifetech CeraFlex™ device works for closing holes in the heart (Atrial Septal Defect) in patients who received it between 2019 and 2022.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Sex | All |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. Industry-sponsored |
| Locations | 7 sites (Curitiba and 6 other locations) |
| Trial ID | NCT05887700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical use of the Lifetech CeraFlex™ Closure System for Atrial Septal Defect (ASD) in a real-world setting. Data will be collected from patients who received the device between 2019 and 2022, with the collection process expected to conclude by the end of 2024. The findings will provide insights into the effectiveness and safety of the device as used in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Atrial Septal Defect who have been implanted with the CeraFlex™ device according to the manufacturer's instructions.
Not a fit: Patients who did not attend 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 Lifetech CeraFlex™ device's performance, potentially leading to improved treatment options for patients with ASD.
How similar studies have performed: While this study is focused on post-market evaluation, similar studies assessing device performance in real-world settings have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions. 2. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents. Exclusion Criteria: Patients did not conduct any follow up visit after hospital discharge.
Where this trial is running
Curitiba and 6 other locations
- Hospital Pequeno Príncipe — Curitiba, Brazil (Not_yet_recruiting)
- Universidade Federal do Ceará — Fortaleza, Brazil (Not_yet_recruiting)
- Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil (Not_yet_recruiting)
- HCOR - Associação Beneficente Síria — São Paulo, Brazil (Not_yet_recruiting)
- Hospital Beneficência Portuguesa — São Paulo, Brazil (Not_yet_recruiting)
- Onassis Cardiac Surgery Center — Kallithea, Greece (Recruiting)
- IRCCS Policlinico San Donato — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Rae Gong, PM
- Email: gongrui@lifetechmed.com
- Phone: (86-755)-86026250-6957
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.