The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
18 - 90 years of age at the time of the study procedure
Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy 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 transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) 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. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist.
Estimated life expectancy of less than 12 months
PVR >5 Wood units
Echocardiographic evidence of severe right ventricular dysfunction
Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
Single group
Laplace TTVR System
DeviceTranscatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation
Technical success
Successful valve implantation
Procedural success
Tricuspid regurgitation of moderate or less
Device success
Freedom from reintervention due to device related complications
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