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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00428103
Eligibility Criteria:
Inclusion Criteria:
* Patients would be at least 18 years old.
* They will have history of congestive heart failure and be in New York Heart Association Class III or IV.
* Their left ventricular ejection fraction will be less or equal to 30%.
* They will have moderate or severe mitral regurgitation as determined by echocardiogram. Echocardiogram's criteria for severe mitral regurgitation will be:
* regurgitant volume greater than 50 ml,
* regurgitant fraction greater than 50% and
* effective regurgitant orifice greater than 40 mm2.
If the quantitative criteria are not available, severity of the MR will be graded qualitative in grades I, II, III, and IV. Patients with mitral regurgitation in grade III and IV will be eligible to be included in the study.
Exclusion Criteria:
* Cancer - Metastatic or any cancer within five years except patients with non- melanoma skin cancer.
* Recent stroke (less than six months).
* Severe COPD (patients with an FEV1 less than .8 liters).
* Patients on inotropic infusion preoperatively.
* Patients in atrial fibrillation.
* Pregnant patients.
* Patients with any other valvular disease that required surgical intervention except tricuspid valve disease.
* Patients that will require surgical ventricular restoration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00428103
Study Brief:
Protocol Section:
NCT00428103