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

Recruiting now

Conditions studied: Atrial Septal Defect (ASD)

In brief

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)

Key facts

Study ID

NCT06700174

Run by

Lifetech Scientific (Shenzhen) Co., Ltd.

People needed

100

Starts

2024-09-24

Expected to finish

2025-03-31

Last updated by the study team

2024-11-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ankara (Bilkent) City Hospital — Ankara, Turkey (Türkiye) (enrolling)
• Gazi Yasargil Woman and Child Hospital — Diyarbakır, Turkey (Türkiye) (enrolling)
• Tepecik Training and Research Hospital — Izmir, Turkey (Türkiye) (enrolling)
• Gaziantep University Hospital — Gaziantep, Turkey (Türkiye)
• SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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