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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT04078867
Eligibility Criteria:
Inclusion Criteria:
* Rheumatic mitral valve disease
* Surgery for mitral valve replacement
* Severe functional tricuspid regurgitation
* Moderate functional tricuspid regurgitation with annular dilatation \> 40 mm
* Moderate functional tricuspid regurgitation with preoperative systolic pulmonary artery pressure (SPAP) \>50 mmHg
Exclusion Criteria:
* Patients with non-rheumatic mitral disease
* Combined mitral and aortic valve replacement
* Mitral valve repair
* Concomitant coronary artery or aortic surgery
* Mild or organic tricuspid regurgitation
* Emergency surgery
* Reoperations
* Invalid or missed data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04078867
Study Brief:
Protocol Section:
NCT04078867