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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT05233202
Eligibility Criteria:
Inclusion Criteria:
* Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation \[effective regurgitant orifice (ERO)\>20mm², or systolic hepatic vein flow blunting or reversal\]
* Written signed informed consent
* Affiliation to the French health care system (Sécurité Sociale)
Exclusion Criteria:
* Age \< 18 years
* Severe organic renal dysfunction defined by creatinine clearance \<30mL/min
* Recent endocarditis (\<3 months)
* Recent myocardial infarction (\<3 months)
* Tricuspid valve perforation or prolapse
* Cardiogenic shock requiring dobutamine support or cardiac assistance
* Severe liver injury (CHILD C)
* Left ventricular obstruction
* Allergy to levosimedan
* Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable
* Pregnant or breastfeeding women
* Females of childbearing potential without effective method of birth control
* Patient on AME (state medical aid) unless exemption from affiliation
* Hypotension with SBP\<90mmHg
* Severe tachycardia
* History of torsade de pointe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05233202
Study Brief:
Protocol Section:
NCT05233202