Minneapolis Heart Institute Foundation (MHIF) continues its leadership research to advance care an 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.”