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NCT07687485
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Conditions: Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency, Severe Heart Valve Disease, Symptomatic Tricuspid Regurgitation
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 700
Sponsor: Laplace Interventional, Inc
Location: Oklahoma Heart Institute Tulsa Oklahoma
Summary
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).
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07687485). StuddyBuddy aggregates publicly available trial information.
