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

LifeTech Scientific

Status: Enrolling

Conditions: Atrial Septal Defect

Treatments: Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System

Study type: Observational

Funder types: Industry

Identifiers

NCT05887700

LT-TS-271-2023-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

145 participants in 1 patient group

ASD subjects

Description:

Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.

Treatment:

Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System