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

July 21, 2026 updated by: Laplace Interventional, Inc
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

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 12-Month Endpoint: All-cause mortality, heart failure hospitalization, tricuspid valve re-intervention
Time Frame: 12 months post-procedure
12-month composite of all-cause mortality, heart failure hospitalization, tricuspid valve re-intervention
12 months post-procedure
Composite of major adverse events (MAEs)
Time Frame: 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
30 days 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
Time Frame: 12 months post-procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Laplace Interventional, Inc

Investigators

  • Principal Investigator: Kashish Goel, MD, Vanderbilt University Medical Center
  • Principal Investigator: Brandon Jones, MD, Providence St. Vincent Medical Center
  • Principal Investigator: Charanjit Rihal, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe