Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT03690492
Eligibility Criteria:
Inclusion Criteria:
* Patient undergoes cardiovascular surgery: CABG, valve reconstruction or replacement, aortic root or ascending aortic surgery, or any other cardiothoracic surgery performed by median sternotomy such as atrial or ventricular septal defect closure, Dor or Morrow procedure, cardiac tumor removal and/or surgical treatment of coronary artery anomalies.
* Patient is able to communicate in English or Dutch
* Patient has been referred by a cardiologist from the Leiden University Medical Center, Cardiological Center Voorschoten, Alrijne Hospital or Haaglanden Medical Center
Exclusion Criteria:
* Patient is \< 18 years old
* Patient is pregnant
* Patient is considered an incapacitated adult
* Patient is unwilling to sign the informed consent form
* Patient undergoes emergency thoracic surgery (INTERMACS 1 or 2)
* Patient has active endocarditis at the time of operation
* Patient is on mechanical circulatory support before operation
* Patient has a ventricular septal rupture
* Patient undergoes extracorporeal membrane oxygenation or ventricular assist device insertion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03690492
Study Brief:
Protocol Section:
NCT03690492