Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System (NCT07687485) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
700 participantsStarted 2026-09
Plain-language 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).
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, so…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a transcatheter tricuspid valve replacement device called LAPLACE, which is still in early testing and hasn't started enrolling patients yet — given where things stand right now, is this something that might realistically be an option for me in the near future, or is standard treatment a better path to pursue first?
2The trial is tracking major adverse events as a primary safety outcome, which suggests the full safety profile of this device in humans isn't yet established — what risks are specifically associated with transcatheter tricuspid valve replacement that I should weigh before considering a device study like this?
3One of the key things this trial is measuring at 12 months is whether patients need a re-intervention on the tricuspid valve — what would happen to me if the LAPLACE device didn't work as intended, and what re-intervention options would still be available?
4Since this trial isn't recruiting yet, are there other approved treatments or existing clinical trials for severe tricuspid regurgitation that I should be considering right now while I wait to see if this study opens?
5The trial is measuring all-cause mortality and heart failure hospitalization at 12 months — based on how severe my tricuspid regurgitation is today, how urgent is my situation, and does that urgency affect whether waiting for a trial like this makes sense?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.