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Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study

Recruitingn/aAges any - anyAllLifetech Scientific (Shenzhen) Co., Ltd.
NCT06700174 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography; 2. The anatomy of ASD is suitable for percutaneous closure; 3. Patients are scheduled to perform ASD closure; 4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent. Exclusion Criteria: 1. Any contraindication for ASD closure; 2. Patients have ostium primum ASD or coronary sinus ASD; 3. Patients who are pregnant or breastfeeding; 4. Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
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What it tests

  • Not listed
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Where

5 sites
Ankara (Bilkent) City Hospital
Ankara, Turkey (Türkiye)
Gazi Yasargil Woman and Child Hospital
Diyarbakır, Turkey (Türkiye)
Gaziantep University Hospital
Gaziantep, Turkey (Türkiye)
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
Tepecik Training and Research Hospital
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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