Follow-up on the AcuMark Sizing Balloon for heart defect treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to confirm the safety and performance of the AcuMark Sizing Balloon used in the closure of atrial septal defects (ASD). It will monitor patients who have been diagnosed with a single secundum ASD and are scheduled for closure procedures. The study will also identify and track any previously unknown side effects related to the device or the procedure itself. By gathering this data, the study seeks to enhance the understanding of the device's impact on patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ankara (Bilkent) City Hospital
  Ankara, Turkey (Türkiye) Recruiting
• Gazi Yasargil Woman and Child Hospital
  Diyarbakır, Turkey (Türkiye) Recruiting
• Tepecik Training and Research Hospital
  Izmir, Turkey (Türkiye) Recruiting
• Gaziantep University Hospital
  Gaziantep, Turkey (Türkiye) Not yet recruiting
• SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
  Istanbul, Turkey (Türkiye) Not yet recruiting

Study contacts

• Study coordinator: Shen Yuanyuan
• Email: shenyuanyuan@lifetechmed.com
• Phone: 86+18504356312

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• Using 3D Echocardiography to Improve Device Closure for Atrial Septal Defect

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.