Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System (TRIUMPH)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System; Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System

Detailed Description

This study is a prospective, multi-center randomized 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).

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Gladney; Phone Number: 763-710-3539; Email: clinical@laplaceint.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.
• Anatomically unsuitable for the Laplace TTVR System

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laplace TTVR System; Transcatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR.	Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System; Transcatheter Tricuspid Valve Replacement
Active Comparator: Edwards EVOQUE TTVR; Transcatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR.	Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System; Transcatheter Tricuspid Valve Replacement
Experimental: Laplace TTVR System Single Arm Cohort; 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.	Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System; Transcatheter Tricuspid Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of major adverse events (MAEs)	A composite of major adverse events (MAEs) at 30 days.	30 days post-procedure
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	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post-procedure

Collaborators and Investigators

• Sponsor: Laplace Interventional, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2038

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CLN-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes