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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
- ClinicalTrials.gov ID
- NCT05887700
- Acronym / sponsor ID
- LT-TS-271-2023-01
- Conditions
- Atrial Septal Defect
- Keywords
- Lifetech, Atrial Septal Defect, ASD, CeraFlex, ASD Closure System
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 6 Oct 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in 2019 or later.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD subjects | – | Device: CeraFlex™ Atrial Septal Defect (ASD) Closure SystemPatients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients did not conduct any follow up visit after hospital discharge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraFlex™ Atrial Septal Defect (ASD) Closure SystemThe 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. | Device | ASD subjects |
Primary outcome
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.
5 secondary outcomes
Incidence of moderate or large residual shunt
Time frame: At procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Time frame: From attempted procedure to 24 months post-implantation
Incidence of death
Time frame: From attempted procedure to 24 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Turkey (Türkiye), Brazil, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 6 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.