Cardiovascular Diseases (CVD), Heart Valve Diseases, Severe Heart Valve Disease, Severe Tricuspid Valve Regurgitation, Symptomatic Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation
Conditions
Brief 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).
Detailed description
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).
Interventions
DEVICETranscatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System
Transcatheter Tricuspid Valve Replacement
DEVICETranscatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
Transcatheter Tricuspid Valve Replacement
Sponsors
Laplace Interventional, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The study will consist of two cohorts: 1. EVOQUE Eligible Cohort: 400 subjects randomized 2:1 (Laplace:EVOQUE) to demonstrate that Laplace is noninferior to EVOQUE. 2. "Suboptimal for Conventional TVI" Cohort: A single group of up to 150 subjects who are deemed suitable for the Laplace valve, deemed not suitable for EVOQUE, and deemed suboptimal for T-TEER.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of major adverse events (MAEs) | 30 days post-procedure | 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 months post-procedure | 12-month composite of all-cause mortality, heart failure hospitalization, tricuspid valve re-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) ≥ 10 points from baseline to 12 months | 12 months post-procedure | Scores range from 0-100, with higher scores generally indicating higher quality of life related to heart failure. |
Contacts
CONTACTRyan Gladney
PRINCIPAL_INVESTIGATORKashish Goel, MD
Vanderbilt University Medical Center
PRINCIPAL_INVESTIGATORBrandon Jones, MD
Providence St. Vincent Medical Center
PRINCIPAL_INVESTIGATORCharanjit Rihal, MD
Mayo Clinic
Outcome results
None listed