New heart valve replacement without open surgery shows early promise
NCT ID NCT06506942
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study is testing a new device called the TRiCares Topaz, which is threaded through a vein to replace the tricuspid valve in the heart. It is for adults with severe tricuspid valve leakage who are not good candidates for open-heart surgery. The study will check if the device is safe and works as intended, focusing on reducing valve leakage and improving patients' ability to walk and their heart failure symptoms.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
TRiCares Topaz Tricuspid Valve Replacement System (a device implanted via catheter to replace the leaky tricuspid valve)
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe tricuspid valve leakage who are too high-risk for open-heart surgery.
What could go wrong
This is a very early feasibility study with only 15 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or device complications.
Disclaimer
Read more
Show less
This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for CARDIOVASCULAR DISEASES are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
-
Columbia University Medical Center/ NewYork Presbyterian Hospital
RECRUITINGNew York, New York, 10032, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
Minneapolis Heart Institute Foundation
RECRUITINGMinneapolis, Minnesota, 55407, United States
Contact Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
Montefiore
RECRUITINGThe Bronx, New York, 10461, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
Northwestern
RECRUITINGChicago, Illinois, 60611, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
Piedmont Healthcare Inc.
RECRUITINGAtlanta, Georgia, 30309, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
St. Michaels Hospital
RECRUITINGToronto, Ontario, Canada
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
The Christ Hospital
RECRUITINGCincinnati, Ohio, 45219, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
University of Michigan Hospital and Health Systems
RECRUITINGAnn Arbor, Michigan, 48109, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact