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Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System

NCT07687485 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-07-22

No results posted yet for this study

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).

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

Interventions

DEVICE

Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System

Transcatheter Tricuspid Valve Replacement

DEVICE

Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System

Transcatheter Tricuspid Valve Replacement

Sponsors & Collaborators

  • Laplace Interventional, Inc

    lead INDUSTRY

Principal Investigators

  • Kashish Goel, MD · Vanderbilt University Medical Center

  • Brandon Jones, MD · Providence St. Vincent Medical Center

  • Charanjit Rihal, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-09-30
Completion
2038-09-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07687485 on ClinicalTrials.gov