Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized pivotal trial comparing the Laplace TTVR system to the Edwards EVOQUE TTVR system in patients with symptomatic severe or greater tricuspid regurgitation. Eligible participants are adults 18 to 90 who remain symptomatic despite optimized medical therapy and meet anatomical criteria for transcatheter repair. The study evaluates safety and efficacy of the Laplace system in a 2:1 randomization and includes follow-up assessments after the procedure. Enrollment is limited to participating centers and requires adherence to post-procedure follow-up visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Oklahoma Heart Institute
  Tulsa, Oklahoma, United States Recruiting
• Ballad Health
  Kingsport, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Kashish Goel, MD — Vanderbilt University Medical Center
• Study coordinator: Ryan Gladney
• Email: clinical@laplaceint.com
• Phone: 763-710-3539

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

• Investigating multiple and mixed heart valve diseases

  This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06235385

• Evaluating the DUO System for treating Tricuspid Regurgitation

  This study is testing a new heart valve system to see if it can help people with severe tricuspid regurgitation feel better and improve their heart function.

  Recruiting at 17 sites CroiValve Limited · Phoenix, Arizona and 17 other locations · NCT05913908

• TRIFORMIS RESILIA heart valve real-world results in tricuspid disease

  A real-world, observational study to see how the Edwards TRIFORMIS RESILIA tricuspid heart valve performs in adults needing tricuspid valve replacement.

  Recruiting Edwards Lifesciences · Carmel, Indiana · NCT07684313

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.