New heart valve device aims to ease severe leak

NCT ID NCT06458907

Not yet recruiting Disease control Sponsor: P+F Products + Features USA Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests a device called TricValve for people with severe tricuspid regurgitation, a condition where a heart valve leaks. The device is implanted in the veins to help blood flow better. About 780 participants will be randomly assigned to get the device plus standard medical therapy or just standard therapy. The goal is to see if the device improves symptoms and reduces hospitalizations.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: TricValve System (a device implanted in the veins to help blood flow)
What this could lead to: If successful, this could offer a new treatment option for people with severe tricuspid regurgitation who have limited alternatives, potentially improving their quality of life and reducing heart failure hospitalizations.
What could go wrong: This is a pivotal trial, but the device is still experimental. Risks include complications from the implant procedure, and it may not work for everyone. The study is not yet recruiting, so results are years away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart failure heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CARDIOVASCULAR DISEASES HEART FAILURE HEART VALVE DISEASES TRICUSPID VALVE DISEASE TRICUSPID VALVE INSUFFICIENCY TRICUSPID VALVE REGURGITATION

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Ascension Medical Group St. Vincent The Heart Center of Indiana

Indianapolis, Indiana, 46260, United States
Baylor Scott & White Medical

Plano, Texas, 75093, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States
Carilion Clinic

Roanoke, Virginia, 24014, United States
Cleveland Clinic

Cleveland, Ohio, 44106, United States

Contact
Delray Medical Center

Delray Beach, Florida, 33484, United States
Endeavor Health

Glenview, Illinois, 60026, United States
HCA Florida Largo Hospital

Largo, Florida, 33770, United States

Contact
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Houston Methodist

Houston, Texas, 77030, United States
Intermountain Heart Institute - Intermountain Medical Center

Murray, Utah, 84107, United States
Kaiser Permanente

San Jose, California, 94118, United States
Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States
MUSC

Charleston, South Carolina, 29425, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
MedStar Washington Hospital Center

Multiple Locations, Washington, 20010, United States
Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Northwell Hospital

Manhasset, New York, 11030, United States
Oregon Health

Portland, Oregon, 97239, United States
Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States
Scripps Memorial Hospital La Jolla

San Diego, California, 92037, United States
Sentara Healthcare

Norfolk, Virginia, 23507, United States
St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States
Tampa General Hospital

Tampa, Florida, 33606, United States
UC Davis Health

Sacramento, California, 95817, United States
UCSF

San Francisco, California, 94143, United States
UPMC Pinnacle

Harrisburg, Pennsylvania, 17107, United States
UVA School of Medicine

Charlottesville, Virginia, 22903, United States
University of Alabama

Birmingham, Alabama, 35233, United States
University of Kansas Medical Center

Kansas City, Kansas, 66103, United States
University of Texas (Memorial Hermann)

Houston, Texas, 77030, United States
Washington University of St Louis

St Louis, Missouri, 63110, United States

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