Atrial Septal DefectNCT05887700
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
An observational study of Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 10 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- CeraFlex™ Atrial Septal Defect (ASD) Closure System
- Type of treatment
- Medical device
- How many people
- 145 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 9 Jul 2024to 30 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
Who may be able to join
- 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.
Who cannot join
- Patients did not conduct any follow up visit after hospital discharge.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Turkey (Türkiye)6 sites
Bilkent City Hospital
Ankara
Uludag University Hospital
Bursa
Gazi Yasargil T&R Hospital
Diyarbakır
Gaziantep University Hospital
Gaziantep
Cam & Sakıra City Hospital
Istanbul
Cemil Tascioglu City Hospital
Istanbul
Brazil3 sites
Hospital Pequeno Príncipe
Curitiba
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
HCOR - Associação Beneficente Síria
São Paulo
About this study
Official title: A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
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.
Read the detailed description
The study intends to collect data from patients who have implanted with the device in 2019 or later.
- Conditions
- Atrial Septal Defect
- Being tested
- CeraFlex™ Atrial Septal Defect (ASD) Closure System
- Keywords
- Lifetech, Atrial Septal Defect, ASD, CeraFlex, ASD Closure System
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraFlex™ Atrial Septal Defect (ASD) Closure SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ASD subjects | Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device. Receives: Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-implantation
Secondary outcomes (5)
Incidence of moderate or large residual shunt
Measured: At procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Measured: From attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Measured: From attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Measured: From attempted procedure to 24 months post-implantation
Incidence of death
Measured: From attempted procedure to 24 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start9 Jul 2024
- Primary completion6 Oct 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887700
- Sponsor's protocol ID
- LT-TS-271-2023-01
- Status last verified
- Oct 2026
- First submitted
- 24 May 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No