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NCT05887700 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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Enrolling by invitation NCT02766569 - International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients N/A
Completed NCT02957201 - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation N/A
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Completed NCT00498446 - Magnetic Resonance Imaging of Atrial Septal Defects
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