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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT01020266
Eligibility Criteria:
This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.
Inclusion Criteria:
* patients who have the indication for aortic or mitral valve replacement
* patients would like to accept the follow-up and sign the informed consent
* patients with heart function of NYHA I-III degree.
Exclusion Criteria:
* pregnant or nursing women
* comorbid with coronary artery disease
* patients with heart function of NYHA IV degree
* renal dysfunction with serum creatinine level\>or=2mg/dl(177umol/L)
* anticipated life span \< 12 months
* enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01020266
Study Brief:
Protocol Section:
NCT01020266