Atrial Septal DefectNCT06849635
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
An observational study of Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 6 sites in Poland.
Trial summary
The objective of this post-market study is to: collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder identify previously unknown side-effects Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect
- How many people
- 139 participants
- Where
- 6 sitesPoland
- Study dates
- 3 Jan 2025to 28 Feb 2026
- 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
- Child, Adult, Older adult
Study population: Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD), who needs endovascular aortic repair.
Who may be able to join
- Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
- Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
- Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.
Who cannot join
- Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
- Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
- Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
- Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
- Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
- Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.
- Patients did not conduct any follow up visit after hospital discharge.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Poland6 sites, 6 recruiting
- Not yet recruiting
G.V.M.Carint Hospital
Myszków
- Not yet recruiting
Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim
Oświęcim
- Not yet recruiting
Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok
Sanok
- Recruiting
Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group
Tychy
Przemyslaw Weglarz, pweglarz@gmail.com
Ewa Konarska Kuszewska, ewakonku@gmail.com
- Not yet recruiting
Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group
Ustroń
- Not yet recruiting
Dr. Tytus Chałubiński County Hospital
Zakopane
About this study
Official title: Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
The objective of this post-market study is to:
- collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder
- identify previously unknown side-effects
Read the detailed description
Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.
- Conditions
- Atrial Septal Defect
- Keywords
- Atrial Septal Defect
- Medical subject headings
- Heart Septal Defects, Atrial
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
- 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)
Successful closure of the defects
With no, trivial or small residual shunt confirmed by Doppler echocardiography
Measured: at procedure, discharge（up to 2 days）and 12 months post-implantation
Incidence of new onset arrhythmia requiring medical treatment
Include medication, intervention or surgical treatment
Measured: From attempted procedure to 2 years post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the study medical device and whether anticipated or unanticipated.
Measured: From attempted procedure to 2 years post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Adverse event that led to any of the following:
- death,
- serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following:
- a life-threatening illness or injury, or
- a permanent impairment of a body structure or a body function including chronic diseases, or
- in-patient or prolonged hospitalization, or
- medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function,
- foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment
Measured: From attempted procedure to 2 years post-implantation
Incidence of death
Death
Measured: From attempted procedure to 2 years post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start3 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (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
- Other
- Enrolment
- 139 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
- NCT06849635
- Sponsor's protocol ID
- LT-TS-27-2025-01
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
- ClinicalTrials.gov ID
- NCT06849635
- Acronym / sponsor ID
- LT-TS-27-2025-01
- Conditions
- Atrial Septal Defect
- Keywords
- Atrial Septal Defect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 27 Feb 2025 (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 study is to:
- collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder
- identify previously unknown side-effects
Detailed description
Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD), who needs endovascular aortic repair.
Key inclusion criteria (3 listed)
- Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
- Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
- Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.
Key exclusion criteria (7 listed)
- Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
- Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
- Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
- Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
- Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedural success
Time frame: 6 months post-implantation
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
Successful closure of the defects
Time frame: at procedure, discharge（up to 2 days）and 12 months post-implantation
Incidence of new onset arrhythmia requiring medical treatment
Time frame: From attempted procedure to 2 years post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time frame: From attempted procedure to 2 years post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame: From attempted procedure to 2 years post-implantation
Incidence of death
Time frame: From attempted procedure to 2 years 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 6 Mar 2025.
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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.
6 sites in 1 country: 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 6 sites in Poland.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. 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?
Contact KaDirr Shemsi (+86-176-2130-9203, kadirr@lifetechmed.com), or a site near the patient. 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 6 Mar 2025.