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

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

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Phase N/A
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Overview

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.

Description

The study intends to collect data from patients who have implanted with the device between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.

Eligibility

Inclusion Criteria:

  1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
  2. 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.

Study details
    Atrial Septal Defect

NCT05887700

Lifetech Scientific (Shenzhen) Co., Ltd.

14 January 2025

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