Follow-up on the Lifetech Cera™ ASD Occluder for heart defect treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group
  Tychy, Poland Recruiting
• 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 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.