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

Recruiting

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

• Registration Number: NCT05887700
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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 between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Study Start: 2024-07-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 145

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.

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Exclusion Criteria

Patients did not conduct any follow up visit after hospital discharge.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD subjects	CeraFlex™ Atrial Septal Defect (ASD) Closure System	Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of Device Deficiencies (DD)	From attempted procedure to 24 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 moderate or large residual shunt	At procedure, 6 months and 12 months post-implantation
Incidence of death	From attempted procedure to 24 months post-implantation

Trial Locations

Locations (7)

Universidade Federal do Ceará; 🇧🇷 Fortaleza, Brazil

Hospital Pequeno Príncipe; 🇧🇷 Curitiba, Brazil

Santa Casa de Misericórdia de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

HCOR - Associação Beneficente Síria; 🇧🇷 São Paulo, Brazil

Hospital Beneficência Portuguesa; 🇧🇷 São Paulo, Brazil

Onassis Cardiac Surgery Center; 🇬🇷 Kallithéa, Greece

IRCCS Policlinico San Donato; 🇮🇹 Milan, Italy