Follow-up on the Lifetech Cera™ ASD Occluder for heart defect treatment
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
This study is looking to see how well the Lifetech Cera™ ASD Occluder works and if it’s safe for people who have had it implanted to fix a heart defect.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 139 (estimated) |
| Sex | All |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. Industry-sponsored |
| Locations | 6 sites (Myszków and 5 other locations) |
| Trial ID | NCT06849635 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect real-world clinical data to confirm the long-term safety and performance of the Lifetech Cera™ ASD Occluder, a device used for the non-surgical closure of atrial septal defects (ASD). The study will enroll 139 subjects who have been implanted with the device between January 1, 2020, and December 31, 2023, and will follow them for 24 months post-implantation. The goal is to identify any previously unknown side effects associated with the device and to evaluate its effectiveness compared to traditional surgical methods.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with secundum atrial septal defect who have received the Lifetech Cera™ ASD Occluder device within the specified timeframe.
Not a fit: Patients with extensive congenital cardiac anomalies requiring surgical repair or those with contraindications to the device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of a less invasive treatment option for patients with atrial septal defects.
How similar studies have performed: Other studies on transcatheter occluder devices have shown promising results, indicating that this approach is gaining acceptance in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD). * Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions. * Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent. Exclusion Criteria: * Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery. * Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement. * Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months. * Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi). * Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization. * Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein. * Patients did not conduct any follow up visit after hospital discharge.
Where this trial is running
Myszków and 5 other locations
- G.V.M.Carint Hospital — Myszków, Poland (Not_yet_recruiting)
- Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim — Oświęcim, Poland (Not_yet_recruiting)
- Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok — Sanok, Poland (Not_yet_recruiting)
- Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group — Tychy, Poland (Recruiting)
- Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group — Ustroń, Poland (Not_yet_recruiting)
- Dr. Tytus Chałubiński County Hospital — Zakopane, Poland (Not_yet_recruiting)
Study contacts
- Study coordinator: KaDirr Shemsi
- Email: kadirr@lifetechmed.com
- Phone: +86-176-2130-9203
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.