Cera™ ASD Occluder Post-Market Clinical Follow-Up Study

Last updated: March 3, 2025
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Pentalogy Of Cantrell

Treatment

N/A

Clinical Study ID

NCT06849635
LT-TS-27-2025-01
  • All Genders

Study Summary

The objective of this post-market study is to:

  • collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder

  • identify previously unknown side-effects

Eligibility Criteria

Inclusion

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 perIFU instructions.

  • Patients or legally authorized representative are willing to the collection andprocessing of his/her data or sign the Informed Consent.

Exclusion

Exclusion Criteria:

  • Patients who have extensive congenital cardiac anomaly which can only be adequatelyrepaired by cardiac surgery.

  • Patients who have sepsis within one month prior to implantation, or any systemicinfection that can't be successfully treated prior to device placement.

  • Patients known to have a bleeding disorder, untreated ulcer or any othercontraindications to aspirin therapy, unless another anti-platelet agent can beadministered for 6 months.

  • Patients who have demonstrated intra-cardiac thrombi on echocardiography (especiallyleft atrial or left atrial appendage thrombi).

  • Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) orcondition (active infection, etc.) would cause the patient to be a poor candidatefor 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.

Study Design

Total Participants: 139
Study Start date:
January 03, 2025
Estimated Completion Date:
February 28, 2026

Study Description

Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.

Connect with a study center

  • G.V.M.Carint Hospital

    Myszków,
    Poland

    Site Not Available

  • Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim

    Oświęcim,
    Poland

    Site Not Available

  • Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok

    Sanok,
    Poland

    Site Not Available

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

    Tychy,
    Poland

    Active - Recruiting

  • Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group

    Ustroń,
    Poland

    Site Not Available

  • Dr. Tytus Chałubiński County Hospital

    Zakopane,
    Poland

    Site Not Available

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