Severe Tricuspid Valve RegurgitationTRIUMPHNCT07687485
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
A study testing Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System and Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System in people with Severe Tricuspid Valve Regurgitation and Tricuspid Valve Regurgitation, run by Laplace Interventional, Inc at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease
- What is being tested?
- Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System and Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2026to Sep 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ballad Health
Kingsport, Tennessee, 37660
Kristi Harkleroad, 423-230-5643, kristi.harkleroad@balladhealth.org
Guarav Rana
- Recruiting
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Ashlee Ritter, 918-579-5865, ashlee.smithritter@oklahomaheart.com
Kamran Muhammad
About this study
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).
Read the 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).
- Conditions
- Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency
- Being tested
- Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
- Medical subject headings
- Tricuspid Valve Insufficiency, Cardiovascular Diseases, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR SystemDevice
Transcatheter Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR SystemDevice
Transcatheter Tricuspid Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Laplace TTVR System | Experimental | Transcatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR. Receives: Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System |
| Edwards EVOQUE TTVR | Active comparator | Transcatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR. Receives: Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System |
| Laplace TTVR System Single Arm Cohort | Experimental | 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. Receives: Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse events (MAEs)
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
Measured: 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
Measured: 12 months post-procedure
Secondary outcomes (1)
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.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start4 Sep 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laplace Interventional, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kashish Goel, MD, Principal investigator, Vanderbilt University Medical CenterBrandon Jones, MD, Principal investigator, Providence St. Vincent Medical CenterCharanjit Rihal, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687485
- Sponsor's protocol ID
- CLN-004
- Acronym
- TRIUMPH
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
- ClinicalTrials.gov ID
- NCT07687485
- Acronym / sponsor ID
- TRIUMPH / CLN-004
- Conditions
- Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Laplace Interventional, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2038 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laplace TTVR System | Experimental | Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR SystemTranscatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR. |
| Edwards EVOQUE TTVR | Active comparator | Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR SystemTranscatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR. |
| Laplace TTVR System Single Arm Cohort | Experimental | Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR SystemTranscatheter 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR SystemTranscatheter Tricuspid Valve Replacement | Device | Laplace TTVR System, Laplace TTVR System Single Arm Cohort |
| Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR SystemTranscatheter Tricuspid Valve Replacement | Device | Edwards EVOQUE TTVR |
Primary outcome
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
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
1 secondary outcome
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) ≥ 10 points from baseline to 12 months
Time frame: 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System and Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System in people with Severe Tricuspid Valve Regurgitation and Tricuspid Valve Regurgitation, run by Laplace Interventional, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Gladney (763-710-3539, clinical@laplaceint.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major adverse events (MAEs) (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.