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.
Parallel
Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System
DeviceTranscatheter Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
DeviceTranscatheter Tricuspid Valve Replacement
Composite of major adverse events (MAEs)
A composite of major adverse events (MAEs) at 30 days consisting of the following components: * Cardiovascular mortality * Myocardial infarction (MI) * All stroke * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\]) * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * New arrhythmia or conduction disorder requiring permanent pacing
Composite 12-Month Endpoint: All-cause mortality, heart failure hospitalization, tricuspid valve re-intervention
12-month composite of all-cause mortality, heart failure hospitalization, tricuspid valve re-intervention
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) ≥ 10 points from baseline to 12 months
Scores range from 0-100, with higher scores generally indicating higher quality of life related to heart failure.
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This trial is not recruiting at the moment. You can still explore other options:
