TRICi-HF Studie

TRICuspid Intervention in Heart Failure Trial (Tric-I-HF Trial)

10/11/2022 to 31/12/2026

Heart failure attributable to severe tricuspid regurgitation
Study Design: This is an investigator-initiated, multi-center, prospective, controlled, randomized, open label clinical study. Threehundredsixty subjects will be enrolled in the study. Randomization will be performed in a 2:1 fasion (TTVT + OMT vs. OMT alone). The primary endpoint of the study will be assessed after 12 months.
Study Duration: First patient first visit, FPFV: Approx. Q4 2021 to Q1 2022
FPFV to “last patient last visit, LPLV”: Approx. 48 months.
Recruitment period (months): Approx. 36 months
Patient follow up starting at baseline is between 36 months (maximum) and 12 months (minimum) depending on the time of recruitment.
Duration of the entire clinical study (months): Approx. 60 months: Approx. 6 months preparation, 48 months “first patient in” to “last patient out”, 6 months
data analysis)
Primary efficacy endpoint:
Composite of time to all-cause mortality or heart failure hospitalization -
whichever occurs first - at a minimum follow-up of 12 months.