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 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT06156592
Eligibility Criteria:
Inclusion Criteria:
* All patients over 18 years of age, irrespective of their gender or ASA physical status
* With severe aortic stenosis or mitral regurgitation
* Undergoing elective aortic or mitral valve repair or replacement
* Eligible for spinal anesthesia up to T1-2 level block for their surgical procedure.
* Able to provide written informed consent
Exclusion Criteria:
* Contraindications to the administration of spinal anesthesia such as pre-existing coagulopathy, local sepsis at the site of insertion
* Hypoxic (SaO2 \< 95%) on room air
* Unable to lie flat and with 15-degree trendelenburg
* The apical four and five chamber window is not accessible on trans-thoracic echocardiography
* Difficult airway requiring awake intubation
* On dialysis
* Redo-valve surgery
* Mixed valvular lesions (more than mild AR or MS)
* Requiring more than one CABG or CPB duration more than 180 minutes
* More than 3 segment Regional Wall Motion Abnormalities
* Severe spine disorders
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06156592
Study Brief:
Protocol Section:
NCT06156592