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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT04339192
Eligibility Criteria:
Inclusion Criteria:
1. Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer using the transthoracic echocardiography.
2. A history of LSVS, including one or multiple procedures of aortic and/or mitral valve repair and/or replacement.
3. Left ventricular ejection fraction (LVEF) \>45%, systolic pulmonary artery pressure \<60 mmHg with pulmonary vascular resistance \<6 woods unit.
4. Age ≥ 18 years.
5. Able to sign Informed Consent forms.
Exclusion Criteria:
1. TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease.
2. Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures.
3. Prior surgical or percutaneous tricuspid valve intervention.
4. Evidence of an acute myocardial infarction in the prior 90 days
5. Contraindications to cardiopulmonary bypass or the expected operative mortality \>30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II).
6. Any comorbidity with life expectancy \<2 years
7. Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol.
8. Pregnancy at the time of randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04339192
Study Brief:
Protocol Section:
NCT04339192