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RecruitingNCT06183684Updated Sep 25, 2026

Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

An interventional study of Laplace TTVR System in Tricuspid Regurgitation, sponsored by Laplace Interventional, Inc. Recruiting at 10 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Laplace Interventional, Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 60 studies in Tricuspid Valve Insufficiency with a site in United States — 28 open to participants now, 36 under way, none of them phase 3. Tricuspid Valve Insufficiency · United States.

Planned enrollment
20th of 42
65 · median 63
Started
2024
with 7 others
No phase
39 of 60
19 open now
Primary completion
2027-12
later than 19 of 35 live
Registered
41st of 60
by date
Lead sponsor
2 of 60
Laplace Interventional, Inc

Among the 60 studies in Tricuspid Valve Insufficiency with a site in United States, this one is the 20th largest by planned enrollment of the 42 interventional ones that give a count, is one of 8 that started in 2024, is one of 39 with no phase, reaches primary completion later than 19 of the 35 other live ones, and was the 41st registered.

Tricuspid Valve Insufficiency

227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.

Browse Tricuspid Valve Insufficiency studies →

Open to participants now

28 of the 60 studies in Tricuspid Valve Insufficiency with a site in United States are open now. Recruiting first, the newest first:

22 more — sign in →

All 28 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 82 Tricuspid Valve Insufficiency studies recruiting now, 68 (83%) set no upper age limit and none (0%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Read the detailed description

Early Feasibility (EFS), prospective, single-arm, multi-center study to evaluate safety and technical feasibility of the Laplace TTVR System in the treatment of severe, symptomatic tricuspid regurgitation patients.

03

Conditions studied

  • Tricuspid Regurgitation
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18 - 90 years of age at the time of the study procedure
  2. Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent.
  3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) using the 5-grade classification.
  4. Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist.
  5. Anatomically suitable for the Laplace TTVR system (with trans-jugular or transfemoral) access
  6. Subject has provided and agrees to return for all required post-procedure follow-up visits

Exclusion criteria

Exclusion Criteria:

  1. Estimated of less than 12 months
  2. PVR >5 Wood units
  3. Echocardiographic evidence of severe right ventricular dysfunction
  4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
  5. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
  6. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator or leadless pacemaker within 90 days prior to the study procedure
  7. Stroke or other major cerebrovascular event within 90-days prior to index procedure
  8. Untreated coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
  9. Bleeding disorders including thrombocytopenia or count \<70,000 mm3 or thrombocytosis (platelet count >700,000 /mm3)
  10. Current or planned pregnancy within next 12 months for women of
  11. Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
  12. 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.
  13. (LVEF) \< 30%
  14. or inability to complete transesophageal or intracardiac echocardiogram
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Tricuspid Valve Replacement

    Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis

    Device: Laplace TTVR System

Interventions

  • DeviceLaplace TTVR System

    Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation

06

What researchers measure

Primary outcomes

  1. Technical success

    Successful valve implantation

    Time frame: During procedure

Secondary outcomes

  1. Procedural success

    Tricuspid regurgitation of moderate or less

    Time frame: During procedure

  2. Device success

    Freedom from reintervention due to device related complications

    Time frame: 30-days post-procedure

07

Study locations

10 of 10 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Dec 2027, 46 months after the start.

Of 55 industry-sponsored interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 70. This study's planned 46 months is above that.

Counting every sponsor, half of 86 studies reached it within 38 months; a quarter within 23 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2023
First posted
Dec 27, 2023
StartActual
Feb 19, 2024
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2032
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06183684
Lead sponsor
Laplace Interventional, Inc
Responsible party
Sponsor
First posted
Dec 27, 2023
Start date
Feb 19, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2032 (estimated)
Last update
Sep 25, 2026

Study contacts

Ryan Gladney
Contact
clinical@laplaceint.com
763-465-9501

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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