The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid regurgitation (TR).
18 - 90 years of age at the time of the study procedure.
Symptomatic TR despite being adequately treated with OMT by the Local Heart Team for at least 30 days prior to the time of study consent.
Severe, massive or torrential tricuspid regurgitation determined by qualifying echocardiogram using the 5-grade classification.
Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local Heart Team and confirmed by the patient selection committee.
Estimated life expectancy of less than 12 months.
Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months.
Severe renal insufficiency defined as eGFR <25 mL/min or requiring chronic renal replacement therapy at the time of screening committee review.
Current history (within last 5 years) of illicit drug use.