Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures
Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery \> 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary connection
New York Heart Association (NYHA) functional class (FC) II or III (assessed by the investigator using the Specific Activity Scale
Women of childbearing potential must have a negative serum pregnancy test use reliable contraception
You may not be if
Pattern of Fontan circulation severity
Deterioration of the Fontan-palliated condition.
Limitations to Cardiopulmonary exercise testing (CPET)
Peak VO2 \< 15 mL/kg/min.
Any known factor or disease that may interfere with treatment compliance or full participation in the study
Clareo Health | Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
