Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
ConditionAtrial Septal Defect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
CeraFlex™ Atrial Septal Defect (ASD) Closure System
DeviceThe 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.
Treatment groups
145 Participants
are divided into 1 treatment groupGroup A: ASD subjects1 intervention
Trial outcomes
Primary outcomes
1
Procedural success
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.
Time frame
6 months post-implantationSecondary outcomes
1
Incidence of moderate or large residual shunt
Time frame
At procedure, 6 months and 12 months post-implantation2
Incidence of device or procedure related Adverse Events (AEs)
Time frame
From attempted procedure to 24 months post-implantation3
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame
From attempted procedure to 24 months post-implantation4
Incidence of Device Deficiencies (DD)
Time frame
From attempted procedure to 24 months post-implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov