Evaluating a new device for replacing the tricuspid valve in patients with severe 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 study is a multi-center, prospective single arm evaluation of the TRiCares Topaz Tricuspid Valve Replacement System. It aims to assess the safety and performance of this innovative device in adult patients suffering from severe tricuspid regurgitation. The study will involve a thorough evaluation by an institutional Heart Team to determine the suitability of patients who are at increased operative risk. Participants will receive the transcatheter valve replacement intervention and will be monitored for outcomes related to safety and device performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria:

* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Where it's running

• Piedmont Healthcare Inc.
  Atlanta, Georgia, United States Recruiting
• Northwestern
  Chicago, Illinois, United States Recruiting
• University of Michigan Hospital and Health Systems
  Ann Arbor, Michigan, United States Recruiting
• Minneapolis Heart Institute Foundation
  Minneapolis, Minnesota, United States Recruiting
• Columbia University Medical Center/ NewYork Presbyterian Hospital
  New York, New York, United States Recruiting
• Montefiore
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Susheel Kodali, MD — NYU
• Study coordinator: Esther Gerteis
• Email: gerteis@tricares.de
• Phone: +41796015318

Similar studies

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

• Investigation of the EVOQUE System for Tricuspid Valve Replacement

  This study is testing a new device for replacing the tricuspid valve in people with heart valve problems to see how safe and effective it is.

  Recruiting at 21 sites Edwards Lifesciences · Bad Berka and 22 other locations · NCT06569602

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• 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

• Multimodal Cardiac MRI to See How the Heart Is Working

  This study tests a comprehensive MRI approach to characterize heart structure and tissue in adults with suspected or confirmed cardiovascular disease.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07617844

• 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

• Evaluating a new device for replacing the tricuspid valve in patients with severe regurgitation

  This study is testing a new device to replace the tricuspid valve in adults with severe regurgitation who can't have traditional surgery to see if it is safe and works well.

  Recruiting at 6 sites TRiCares · Aalst and 7 other locations · NCT06581471

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.