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 is a prospective, multi-center study aimed at assessing the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System. The study involves adult patients diagnosed with severe tricuspid regurgitation, who are considered at increased risk for traditional surgery. Participants will receive the transcatheter valve replacement, and outcomes will be monitored to evaluate the device's effectiveness and safety. The study is designed as a single-arm trial, meaning all participants will receive the same intervention without a control group.

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

• Algemeen Stedelijk Ziekenhuis
  Aalst, Belgium Recruiting
• ZNA Middelheim
  Antwerp, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• Cliniques Universitaires Saint-Luc UCL
  Brussels, Belgium Recruiting
• AZ Delta
  Roeselare, Belgium Recruiting
• Ludwig Maximilian University Hospital
  Munich, Germany Recruiting

Study contacts

• Principal investigator: Jörg Hausleiter, MD — LMU Munich
• 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.

• 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

• 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

• 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 valve problems to see if it is safe and works well.

  Recruiting at 10 sites TRiCares · Atlanta, Georgia and 9 other locations · NCT06506942

• Abnormal menstrual bleeding in women on antithrombotic drugs after heart surgery

  This study looks at whether women on blood thinners after heart surgery have abnormal menstrual bleeding and what factors might put some at higher risk.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07870941

• AI-powered ECG to help diagnose and predict outcomes in heart disease

  Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07856472

• Colchicine for preventing cardiovascular disease in adults with type 2 diabetes

  A 24-week study will test whether low-dose colchicine can help protect blood vessels in adults with type 2 diabetes who have not yet developed artery disease, compared with a placebo.

  Recruiting Phase 2 Tan Tock Seng Hospital · Singapore, Singapore · NCT07837934

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.