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

Atrial Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05887700
• Other study ID #: LT-TS-271-2023-01
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Rae Gong, PM
• Phone: (86-755)-86026250-6957
• Email: gongrui[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 145
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Atrial Septal Defect
• Heart Septal Defects
• Heart Septal Defects, Atrial

Intervention

Device:
• CeraFlex™ 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.

Locations

Country	Name	City	State
Brazil	Hospital Pequeno Príncipe	Curitiba
Brazil	Santa Casa de Misericórdia de Porto Alegre	Porto Alegre
Brazil	Instituto de Cardiologia de Santa Catarina	São José
Brazil	HCOR - Associação Beneficente Síria	São Paulo
Brazil	Hospital Beneficência Portuguesa	São Paulo
Greece	Onassis Cardiac Surgery Center	Kallithéa
Italy	IRCCS Policlinico San Donato	Milan
Italy	Santa Maria della Misericordia - Ospedale di Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Countries where clinical trial is conducted

Brazil,  Greece,  Italy, 

Outcome

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