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 Type
OBSERVATIONAL
Enrollment
100
Ankara (Bilkent) City Hospital
Ankara, Turkey (Türkiye)
RECRUITINGGazi Yasargil Woman and Child Hospital
Diyarbakır, Turkey (Türkiye)
RECRUITINGGaziantep University Hospital
Gaziantep, Turkey (Türkiye)
Sizing success rate
The size of the selected occluder is proper by echocardiography observing
Time frame: 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.
Time frame: From attempted procedure to discharge, up to 14 days
Device success rate
Study device is successfully delivered in place and dilated without rupture and is successfully withdrew.
Time frame: 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.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
NOT_YET_RECRUITINGTepecik Training and Research Hospital
Izmir, Turkey (Türkiye)
RECRUITING