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Completed

NCT Number: NCT05939713

Cera™ VSD Occluder Post Market Clinical Follow-up

The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.

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Key information

Conditions

Ventricular Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

Loading trial locations.

About this study

The study intends to collect data from patients who have implanted with the device before 2022. The study is expected to completed by the end of 2024.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cera™ VSD occluder implantation

Device

To collect data from patients who have implanted with the device before 2022.

Primary outcomes

  1. Procedural success

    Time frame: 6 months post-implantation

    Defined as a composite of:

    • Absence of complete atrioventricular block (third degree AV block) needing pacemaker implantation, device embolization, severe aortic regurgitation requiring surgical repair or device or procedure related death, assessed at 6 months post-implantation.
    • Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation .

Secondary outcomes

  1. Incidence of moderate or large residual shunt

    Time frame: at procedure, 6 months and 12 months post-implantation

  2. Incidence of new onset complete AV block (third-degree AV block) or any new onset arrhythmia needing for pacemaker implantation, or new onset left bundle branch block (LBBB);

    Time frame: from attempted procedure to 24 months post-implantation

  3. Incidence of new onset second-degree AV block

    Time frame: from attempted procedure to 24 months post-implantation

  4. Incidence of new onset severe aortic or tricuspid regurgitation

    Time frame: from attempted procedure to 24 months post-implantation

  5. Incidence of device-related thrombosis (DRT)

    Time frame: from attempted procedure to 24 months post-implantation

  6. Incidence of device embolization

    Time frame: from attempted procedure to 24 months post-implantation

  7. Incidence of device or procedure related Adverse Events (AEs)

    Time frame: from attempted procedure to 24 months post-implantation

  8. Incidence of device or procedure related Serious Adverse Events (SAEs)

    Time frame: from attempted procedure to 24 months post-implantation

  9. Incidence of Device Deficiencies (DD)

    Time frame: from attempted procedure to 24 months post-implantation

  10. Incidence of death

    Time frame: from attempted procedure to 24 months post-implantation

Sponsors and collaborators

Lead sponsor

Cardiac Children's Foundation Taiwan

Other

Registry information

Official study title

A Multi-center, Single Arm, Real-World Registry Assessing the Clinical Use of the Cera™ VSD Occluder

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2023
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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