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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT03567668
Eligibility Criteria:
Inclusion Criteria:
* evidence of normal or preserved left ventricular systolic function (defined as left ventricular ejection fraction \[LVEF\] \>50%);
* native mitral regurgitation of grade moderate or greater;
* with or without systemic-to-pulmonary shunting necessitating concomitant surgical repairs, regardless of pulmonary arterial pressure or pulmonary artery wedge pressure.
Exclusion Criteria:
* functional single ventricle;
* rheumatic mitral diseases;
* Eisenmenger syndrome;
* aortopathy, transposition of the great arteries, obstructions of ventricular outflow tract, malignant arrhythmias, cardiomyopathy, microbiological identification of infective endocarditis;
* a history of pericardiotomy or intervention therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
18 Years
Study:
NCT03567668
Study Brief:
Protocol Section:
NCT03567668