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NCT Number: NCT05887700

Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up

The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.

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Key information

Conditions

Atrial 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, Atrial

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Pequeno Príncipe, Curitiba, Brazil

Loading trial locations.

About this study

The study intends to collect data from patients who have implanted with the device in 2019 or later.

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 Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
  • 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.

Treatment and study plan

CeraFlex™ Atrial Septal Defect (ASD) Closure System

Device

The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects.

Primary outcomes

  1. Procedural success

    Time frame: 6 months post-implantation

    Procedural success is defined as a composite of:

    • Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/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 device or procedure related Adverse Events (AEs)

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

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

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

  4. Incidence of Device Deficiencies (DD)

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

  5. Incidence of death

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rae Gong

CONTACT

[email protected]

(86-755)-86026250-6957

Sponsors and collaborators

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2023
Registry last updated
May 26, 2026

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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