Laplace Interventional, Inc
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-procedu…
Transcatheter Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement
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