Laplace TTVR System for Tricuspid Regurgitation
(TRIUMPH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Kashish Goel, MD
Principal Investigator
Vanderbilt University Medical Center
Brandon Jones, MD
Principal Investigator
Providence St. Vincent Medical Center
Charanjit Rihal, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 18–90 who have severe tricuspid valve leakage (tricuspid regurgitation) causing symptoms, even after standard medical treatment. Participants must be suitable for a transcatheter valve replacement and able to attend follow-up visits.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Trial Overview
The study compares two minimally invasive procedures: the Laplace TTVR System and the Edwards EVOQUE TTVR System, both designed to replace the faulty tricuspid heart valve without open-heart surgery.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Transcatheter tricuspid valve replacement with Laplace TTVR System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with the Active Comparator EVOQUE TTVR and are suboptimal T-TEER candidates.
Transcatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR.
Transcatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laplace Interventional, Inc
Lead Sponsor
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