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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT05706857
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years of age.
* Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery.
* The patient's desire to participate in the clinical trial verified by signing the informed consent.
Exclusion Criteria:
1. Pregnancy.
2. Emergent surgery or cardiorespiratory arrest.
3. Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.
4. Aortic arch procedures.
5. Procedures in which hypothermia \< 28ºC of temperature is expected during the intervention.
6. Minor cardiac surgery procedures.
7. Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting).
8. Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).
9. Active endocarditis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05706857
Study Brief:
Protocol Section:
NCT05706857