50th Patient Enrolled in Abbott’s TRILUMINATE Clinical Study Advancing Options for Tricuspid Regurgitation

MHIF Valve Science Center Accelerates Research for Heart Valve Disease
Jun 21, 2021
Dr. Sorajja and Kate Jappe with MHIF's 50th Triluminate patient

Minneapolis Heart Institute Foundation (MHIF) continues its leadership research to advance care and outcomes for patients living with heart valve disease, reaching an important milestone – the 50th patient enrolled in Abbott’s TRILUMINATE pivotal clinical trial. This research represents the dedication of the structural heart team at the MHIF Valve Science Center to advance options for patients. The MHIF team was the first to participate in the trial that investigates the use of Abbott’s first-of-its-kind TriClip™ system to offer minimally invasive clip-based repair of the tricuspid valve. The MHIF center remains the top enroller in this important research.  

The TRILUMINATE study is the first pivotal clinical trial for a new technology to treat tricuspid regurgitation (leaky tricuspid heart valve) and will gather data used by the manufacturer of the device, Abbott, to seek regulatory approval to commercialize the device. The study is a prospective, randomized, multicenter trial of the TriClip device in symptomatic patients with severe tricuspid regurgitation who have been determined to be at intermediate risk for morbidity and mortality with tricuspid valve surgery. There are currently no non-surgical treatments available for patients, leaving many with advanced disease without any options for the life-threatening condition.

MHIF is one of 80 centers nationally participating in this research trial, involving the collaboration of a leading multi-disciplinary team of physicians and researchers at the MHIF Valve Science Center.

“This research represents a first-of-its-kind advance for patients with severe tricuspid regurgitation and is a great example of the innovation that has taken place over the last decade for heart valve disease,” said Paul Sorajja, MD, national principal investigator for the TRILUMINATE clinical study and Roger L. and Lynn C. Headrick Chair for Valve Research at the MHIF Valve Science Center. “I am proud to be part of an amazing team of physicians and researchers who are inspired every day by the patients we are able to help through research. I want to  congratulate the entire team of individuals who have helped us get from the first-in-the-world to the 50th patient enrolled in a study that has the potential to change the trajectory of this disease for so many patients in the future.”

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The Minneapolis Heart Institute Foundation® (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, we are dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.

Thanks to the generosity of donors like you, we can continue this life-saving work. Please make a gift to support the area of greatest need.

Research Milestone: FDA approves device used as alternative to open-heart

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Triclip team

We are honored to celebrate the culmination of years of research that has resulted in new technologies for patients! In the few last weeks, we announced a similar research milestone with the FDA approval of the TriClip system for tricuspid regurgitation. We celebrated this important milestone with local media KSTP-TV, who spotlighted the importance of this new technology. We were proud to be a leading clinical site led by Global PI Dr. Paul Sorajja and the MHIF research team who contributed significant data to the pivotal trial.