Atrial Septal Defect (ASD)NCT06700174
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
An observational study of Atrial Septal Defect (ASD), run by Lifetech Scientific (Shenzhen) Co., Ltd. at 5 sites in Turkey (Türkiye).
Trial summary
The objective of this PMCF study is to: confirm the safety and performance of the AcuMarkTM Sizing Balloon identify previously unknown side-effects monitor the identified side-effects (related to the procedure or to the medical devices) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect (ASD)
- How many people
- 100 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 24 Sep 2024to 31 Mar 2025
- 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 echocardiographic confirmation of a single secundum atrial septal defect (ASD) who are scheduled to undergo ASD closure.
Who may be able to join
- Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
- The anatomy of ASD is suitable for percutaneous closure;
- Patients are scheduled to perform ASD closure;
- Patients or legally authorized representative(s) who are willing and capable of providing informed consent.
Who cannot join
- Any contraindication for ASD closure;
- Patients have ostium primum ASD or coronary sinus ASD;
- Patients who are pregnant or breastfeeding;
- Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Ankara (Bilkent) City Hospital
Ankara
ECE Ibrahim, dribrahimece@gmail.com
ECE Ibrahim
- Recruiting
Gazi Yasargil Woman and Child Hospital
Diyarbakır
ALDUDAK Bedri, draldudak@hotmail.com
ALDUDAK Bedri
- Not yet recruiting
Gaziantep University Hospital
Gaziantep
BASPINAR Osman, osmanbaspinar@hotmail.com
BASPINAR Osman
- Not yet recruiting
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul
DEMIR Halil Ibrahim, drdemir1@gmail.com
DEMIR Halil Ibrahim
- Recruiting
Tepecik Training and Research Hospital
Izmir
NARIN Nazmi, nazmi.narin@gmail.com
NARIN Nazmi
About this study
Official title: A Multicenter, Prospective, Single-arm, Observational Study
The objective of this PMCF study is to:
- confirm the safety and performance of the AcuMarkTM Sizing Balloon
- identify previously unknown side-effects
- monitor the identified side-effects (related to the procedure or to the medical devices)
- Conditions
- Atrial Septal Defect (ASD)
- Medical subject headings
- Heart Septal Defects, Atrial
What is being measured
The primary outcome is the main question the study is designed to answer.
Sizing success rate
The size of the selected occluder is proper by echocardiography observing
Measured: At procedure
Incidence of major adverse events (MAEs)
Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention.
Measured: From attempted procedure to discharge, up to 14 days
Secondary outcomes (4)
Device success rate
Study device is successfully delivered in place and dilated without rupture and is successfully withdrew.
Measured: At procedure
Incidence of procedure and/or device-related complications
Complications include vessel perforation/dissection, thromboembolism, hematoma, arrythmia, expansion of the defect, balloon migration, obstruction of venous return from the inferior vena cava.
Measured: From attempted procedure to discharge, up to 14 days
Incidence of Serious Adverse Events
Measured: From attempted procedure to discharge, up to 14 days
Incidence of Device Deficiency (DD)
Measured: From attempted procedure to discharge, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start24 Sep 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal Defect (ASD)Studies 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
- Prospective
- Enrolment
- 100 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
- NCT06700174
- Sponsor's protocol ID
- LT/TS/571I-2023
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single-arm, Observational Study
- ClinicalTrials.gov ID
- NCT06700174
- Acronym / sponsor ID
- LT/TS/571I-2023
- Conditions
- Atrial Septal Defect (ASD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Nov 2024 (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 PMCF study is to:
- confirm the safety and performance of the AcuMarkTM Sizing Balloon
- identify previously unknown side-effects
- monitor the identified side-effects (related to the procedure or to the medical devices)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with echocardiographic confirmation of a single secundum atrial septal defect (ASD) who are scheduled to undergo ASD closure.
Key inclusion criteria (4 listed)
- Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
- The anatomy of ASD is suitable for percutaneous closure;
- Patients are scheduled to perform ASD closure;
- Patients or legally authorized representative(s) who are willing and capable of providing informed consent.
Key exclusion criteria (4 listed)
- Any contraindication for ASD closure;
- Patients have ostium primum ASD or coronary sinus ASD;
- Patients who are pregnant or breastfeeding;
- Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
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
Sizing success rate
Time frame: At procedure
The size of the selected occluder is proper by echocardiography observing
Incidence of major adverse events (MAEs)
Time frame: From attempted procedure to discharge, up to 14 days
Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention.
4 secondary outcomes
Device success rate
Time frame: At procedure
Incidence of procedure and/or device-related complications
Time frame: From attempted procedure to discharge, up to 14 days
Incidence of Serious Adverse Events
Time frame: From attempted procedure to discharge, up to 14 days
Incidence of Device Deficiency (DD)
Time frame: From attempted procedure to discharge, up to 14 days
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 21 Nov 2024.
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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.
5 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 (ASD), run by Lifetech Scientific (Shenzhen) Co., Ltd. at 5 sites in Turkey (Türkiye).
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 4 inclusion and 4 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). 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 Shen Yuanyuan (86+18504356312, shenyuanyuan@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sizing success rate (time frame: At procedure). The study lists 2 primary outcomes in all. 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 21 Nov 2024.