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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05887700

Enrollment

145

Registered

2023-06-05

Start date

2024-07-09

Completion date

2027-06-30

Last updated

2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Septal Defect

Keywords

Lifetech, Atrial Septal Defect, ASD, CeraFlex, ASD Closure System

Brief summary

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.

Detailed description

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

Interventions

DEVICECeraFlex™ Atrial Septal Defect (ASD) Closure System

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
Procedural success	6 months post-implantation	Procedural success is defined as a composite of: 1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation. 2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation.

Secondary

Measure	Time frame
Incidence of moderate or large residual shunt	At procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)	From attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)	From attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)	From attempted procedure to 24 months post-implantation
Incidence of death	From attempted procedure to 24 months post-implantation

Countries

Brazil, Greece

Contacts

CONTACTRae Gong

gongrui@lifetechmed.com(86-755)-86026250-6957

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026