Doctors Treat First Patients in TRIUMPH Valve Trial

Structural heart teams at two medical centers have begun a pivotal clinical study testing a new tricuspid valve device.

Updated on Oct. 31, 2026 in Heart Disease

Doctors Treat First Patients in TRIUMPH Valve Trial

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Medical teams have treated the first three patients in the TRIUMPH clinical trial, a pivotal study evaluating a new transcatheter tricuspid valve replacement device. The procedure aims to address tricuspid regurgitation using either transjugular or transfemoral access.

Why it matters

The study evaluates the safety and efficacy of the Laplace Interventional device, providing a potential new treatment option for patients suffering from tricuspid regurgitation. This trial marks a significant step in developing less invasive methods for structural heart interventions.

The TRIUMPH trial uses a 2:1 randomization ratio for patients receiving the new device against a commercially available alternative. The study is a prospective, multicenter investigation currently active at participating sites.

The players

Laplace Interventional

This medical device company is the manufacturer of the new transcatheter tricuspid valve replacement technology.

Ballad Health

This healthcare system serves as one of the clinical trial sites located in Kingsport, Tennessee.

Oklahoma Heart Institute

This specialized cardiology center is a participating site for the ongoing clinical investigation in Tulsa, Oklahoma.

The details

Structural heart teams performed the procedures at Ballad Health in Kingsport, Tennessee, and the Oklahoma Heart Institute in Tulsa. The Laplace Interventional device is specifically designed to treat tricuspid regurgitation via transjugular or transfemoral access.

Timeline

  1. The first patients were treated in October 2026.

The Big Picture

The study follows a standard pipeline for medical device approval, mirroring previous pivotal clinical trials for transcatheter heart valve technology. This research extends current efforts to address structural heart conditions through less invasive surgical interventions.

This clinical trial represents an emerging experimental option for patients who may not qualify for or desire traditional open-heart surgery. As the study progresses, it could lead to new, less invasive treatment pathways for those living with chronic tricuspid valve issues.

The takeaway

The initiation of the TRIUMPH trial underscores the growing medical focus on transcatheter solutions for complex heart valve conditions. Patients experiencing symptoms of tricuspid regurgitation should consult with their cardiologists about whether clinical trials might offer new treatment possibilities.

Further reading

For more information on current treatment methods, visit the Heart Disease section.

Source note: This article includes information reported by Cardiovascular Business.

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Do you support the use of experimental devices in clinical trials to advance heart surgery?