top of page
Seniors Enjoying Laughter

INFORMATION FOR PATIENTS

TRIVITA Logo v2.png

What is Tricuspid Regurgitation?

Tricuspid valve regurgitation is a type of heart valve disease. It is a condition where the heart’s tricuspid valve doesn’t close tightly, allowing blood to leak backward into the heart when the heart pumps [1].    A leaking heart valve can make the heart work harder by reducing blood flow to critical organs and building pressure within the heart. When you first learn you have tricuspid regurgitation, your doctor may prescribe medication to manage your symptoms.

 

Over time, patients with tricuspid regurgitation (TR) may develop additional symptoms which are not able to be treated by medication alone, such as [2]:

  • Shortness of breath

  • Pulsing in neck veins

  • Decreased urination

  • Swelling in the abdomen, legs, or feet

  • Fatigue or weakness that lasts several days or more

What is the VDYNE Transcatheter Tricuspid Valve Replacement System? 

The VDYNE transcatheter tricuspid valve replacement system is an investigational device designed to replace your native tricuspid valve without open-heart surgery.   During the VDYNE procedure, your doctor places a thin tube (catheter) through a vein in your leg to reach your heart. The VDYNE system is delivered through this tube and into your heart to replace your tricuspid valve.

​

 Watch the VDYNE valve procedure

​

About the TRIVITA Trial

The TRIVITA clinical trial is a medical research study to determine the safety and effectiveness of the VDYNE system in patients with severe or greater tricuspid regurgitation.

Common Questions

What is a clinical trial?

Before new medical devices  can be offered to the public, they are tested in a lab to make sure they are safe and will work when implanted in a patient heart.  Once this testing is complete, the medical device is approved for use in human clinical trials.  A clinical trial is a type of research conducted with volunteers that studies recently developed medications, devices or treatments 

.

What you should know about the TRIVITA clinical trial

This trial is intended to evaluate the safety and effectiveness of the VDYNE System with medication (also called Optimal Medical Therapy, or OMT). The performance of the VDYNE System will be compared to another transcatheter valve (Evoque [5]) that was recently approved by FDA.   Ask your doctor about the benefits and risks of participation in the VDYNE study compared to the benefits and risks of treatment with Evoque, as well as the benefits and risks of remaining on medication without tricuspid valve replacement.

What is the TRIVITA clinical trial?

The TRIVITA clinical trial will evaluate the safety and effectiveness of the VDYNE System, an investigational medical device designed to treat severe tricuspid regurgitation [6].

​

A minimally invasive procedure will be used to replace your tricuspid valve in this clinical trial.

You may receive the VDYNE replacement valve (Test Group) or the Evoque replacement valve (Control Group) while remaining on your medication.

​

This clinical study will allow doctors to understand how the VDYNE System works in patients with severe TR.

What can you expect?

You will be told about the possible risks and benefits of joining the TRIVITA study.  You will have plenty of time to ask questions.   Joining the study is your choice.

​

You will be placed by chance into one of two groups.  One group (Test group) will receive the VDYNE valve with standard care including OMT.   The other group (Control group)  will receive the Evoque valve with standard care, including OMT.

​

Doctors will watch you closely during the procedure and after the device is placed.   You will need to come back for several check-ups over the next 5 years.

​

During the study, a group of doctors and specialists—your Heart Team—will help and support you the whole time.

What are the costs?

There is no additional cost for you to participate in a clinical trial. You will still be responsible for the cost of your standard ongoing medical care, including deductibles and co-payments that would be billed to you or your health insurance provider.

​

The tests or procedures required by the research trial that would not otherwise be be covered by your insurance provider (such as Medicare) will be paid by VDYNE, Inc., the sponsor of the trial.

​

Please check with your health care provider for further information

References:

  1. American Heart Association. (n.d.). Heart valve problems and disease. Retrieved from https://www.heart.org/

  2. American Heart Association:  Problem: Tricuspid Valve Regurgitation.    https://www.heart.org/en/health-topics/heart-valve-problems-and-disease/heart-valve-problems-and-causes/problem-tricuspid-valve-regurgitation?utm_source=chatgpt.com​

  3. Clinical trials: what patients need to know. US Food and Drug Administration. Updated January 4, 2018.  https://www.fda.gov/patients/ clinical-trials-what-patients-need-know

  4. Inside Clinical Trials: Testing Medical Products in People. US Food and Drug Administration. Updated November 6, 2014.   https://www.fda.gov/drugs/drug- information-consumers/inside-clinical-trials-testing-medical-products-people. 

  5. Evoque is a trademark of Edwards Lifesciences Corporation.

  6. VDyne TRIVITA pivotal clinical trial protocol (TRIVITA).  ClinicalTrials.gov identifier: NCT07516444

​

     

Caution: Investigational device.  Limited by Federal (or United States) law to investigational use. 

 

Important safety information

           

 This device is not available for marketing or commercial sale in the United States.

 

VDyne, Inc. is the sponsor of the TRIVITA trial.

VDyne, Inc.  10900 73rd Avenue North Eagle Lake Business Center, Suite 116. Maple Grove, MN 55369  USA

VDyne.com

​

bottom of page