Clinical Research Directory

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Anatomically unsuitable for the Laplace TTVR System