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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT07251660
Eligibility Criteria:
Inclusion Criteria:
* Patients of any age and gender.
* Undergoing elective, isolated mitral or aortic valve surgery.
* Considered suitable for either:
* MIVS via right thoracotomy, or
* Conventional valve surgery , as decided by the operating surgical team.
* Patients giving written informed consent.
Exclusion Criteria:
* Emergency or redo cardiac surgeries
* Concomitant cardiac procedures (e.g., CABG, multiple valve replacements)
* Ejection Fraction \<30%
* Severe pulmonary hypertension (identified as the mean pulmonary artery pressure (mPAP) exceeding 45 mmHg on echocardiography, as outlined by the AHA guidelines(10).
* Active systemic infections or sepsis at the time of surgery
* Refusal to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07251660
Study Brief:
Protocol Section:
NCT07251660