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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00955266
Eligibility Criteria:
Inclusion Criteria:
* Men and women greater than 18 years of age
* Undergoing primary elective valve surgery at Brigham and Women's Hospital
* Consented for Transesophogeal Echocardiography (TEE) as part of routine intra-operative care and monitoring
Exclusion Criteria:
* Patients not consented for TEE as part of routine intra-operative care
* Any absolute contraindication to TEE
* Ionized calcium level \< 0.80 mmol/L near separation from CPB
* Myocardial infarction (MI) or acute coronary syndromes \< 3 months prior to surgery due to the presence of pre-operative diastolic dysfunction in infarcted or ischemic myocardium
* Ejection fraction (EF) \< 35%
* Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler
* Heart rate (HR) \> 100 during 2 data point collections due to E / A wave superimposition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00955266
Study Brief:
Protocol Section:
NCT00955266