A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Septal Defect
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Enrollment
- 145
- Locations
- 7
- Primary Endpoint
- Procedural success
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
- •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.
Outcomes
Primary Outcomes
Procedural success
Time Frame: 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 Outcomes
- 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)