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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT02435303
Eligibility Criteria:
Inclusion Criteria:
* New York Heart Association Functional class (NYHA Fc) ≥ 2 dyspnea which was sustained till one year after the previous mitral valve surgery (repair or replacement)
* TR Vmax ≥ 3.5m/s by echocardiography
* Normal left ventricle ejection fraction (EF ≥ 50%)
* Pulmonary vascular resistance ≥ 3 Wood Unit or diastolic pressure gradient ≥ 7mmHg by cardiac catheterization
Exclusion Criteria:
* Other valve disease more than moderate degree (ex. aortic stenosis, aortic regurgitation)
* Liver cirrhosis
* Chronic renal failure with serum creatinine ≥ 1.7mg/dL
* Lung disease (ex. chronic obstructive pulmonary disease, Asthma)
* Thyroid dysfunction
* Other causes which can lead to pulmonary hypertension
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02435303
Study Brief:
Protocol Section:
NCT02435303