Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System

Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System

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).

This study is a prospective, multi-center randomized (2:1) controlled pivotal trial to evaluate the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System compared to the Edwards EVOQUE TTVR System for the treatment of symptomatic subjects with severe or greater tricuspid regurgitation (TR).

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.
• Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits.
• Anatomically suitable for the Laplace TTVR system.

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.
• Current history (within last 5 years) of illicit drug use.
• Stroke or other major cerebrovascular event within 90-days prior to index procedure.
• Current or planned pregnancy within next 12 months for women of childbearing potential.
• Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
• Anatomically unsuitable for the Laplace TTVR System