MINNEAPOLIS – Minneapolis Heart Institute Foundation® (MHIF) today presented primary outcomes from the TRILUMINATE™ Pivotal clinical trial showing the TriClip™ (manufactured by Abbott) catheter-based, non-surgical treatment demonstrated superiority to medical therapy in improving quality of life and reducing tricuspid regurgitation (TR). Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair for the MHIF Valve Science Center and national principal investigator for the TRILUMINATE Pivotal trial, presented the late-breaking, clinical trial data at the American College of Cardiology’s 72nd Annual Scientific Session Together with World Heart Federation’s World Congress of Cardiology (ACC/WCC) in New Orleans. Dr. Sorajja is also lead author of the manuscript, “Transcatheter Repair for Patients with Tricuspid Regurgitation,” simultaneously published in the New England Journal of Medicine.
“The data confirm the benefit of this advanced repair option for tricuspid valve disease that can safely address symptoms of the disease and allow patients to live life to the fullest,” said Dr. Sorajja. “Our team has contributed to this research advancing options from the beginning, including the first-in-the-world procedure utilizing this new technology. With support from a multi-disciplinary team across cardiac surgery and imaging, we are proud to drive ongoing innovation that is changing the course of tricuspid valve disease for patients.”
Key Findings from the TRILUMINATE Pivotal Study
The trial met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group (win ratio 1.48, p=0.02), primarily driven by improvement in quality of life. Mortality or tricuspid valve surgery and heart failure hospitalizations did not appear different between the groups at one year. Other positive findings include:
- Significant reduction in TR grade. Significant reduction in TR to moderate or less (grade < 2) was achieved in 87% of patients with the device at 30 days vs. 4.8% in the control group, with TR reduction sustained and durable at one year.
- Significant improvement in quality of life. 50% of patients who received the device achieved at least a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life) at one year vs. 26% in the control group.
- A strong safety profile. At 30 days, only 1.7% of patients who received the device experienced major adverse events, with no urgent surgery or endocarditis. There were no occurrences of device embolization or device thrombus.
MHIF was the top enroller (enrolling the first and largest number of patients) of all 75 clinical sites participating in this research trial in the United States, Canada and Europe. MHIF led the way as the first to provide this technology to a patient as part of early research in 2017 and completed the first-in-the-world enrollment in the TRILUMINATE Pivotal trial in September 2019.
The TRILUMINATE Pivotal study is a prospective, randomized, controlled trial to assess percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe TR and will provide data for the manufacturer of the device, Abbott, to seek regulatory approval to commercialize the technology. The TriClip tricuspid valve repair system is built on the MitraClip™ system, a proven technology that is widely used for the treatment of mitral valve regurgitation. MHIF is a leader in research to advance treatments for heart valve disease and was also involved in studies that were used to gain regulatory approval for the MitraClip system.
Severe tricuspid regurgitation is a debilitating condition that is often associated with morbidity and poor quality of life. In the U.S. alone, approximately one in 30 people over the age of 65 have moderate to severe tricuspid regurgitation. Despite the prevalence of tricuspid valve disease, the tricuspid valve is often referred to as the "forgotten heart valve" as treatment options are limited. There are currently no approved non-surgical, minimally invasive treatments for people with severe tricuspid regurgitation in the U.S., which is why TriClip represents an important option for patients.
About Minneapolis Heart Institute Foundation®
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
Scientific Innovation and Research – MHIF is a recognized leader across all specialties of heart and vascular research. Each year, MHIF leads more than 220 research studies with more than 2,200 patients and publishes more than 250 articles to share learnings from research. MHIF research has improved the standard of care around the world through protocols like Level One for heart attack, which significantly improved outcomes and survival for patients.
Education and Outreach – MHIF provides more than 11,000 hours of education each year putting its research into practice to improve outcomes among health care providers. This commitment extends to patients and caregivers through community health and education events to raise awareness of heart care and research, engaging individuals in their own health.
The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and engages in cutting-edge research initiatives with its physician partners from the Allina Health Minneapolis Heart Institute® at Abbott Northwestern Hospital and at 38 community sites across Minnesota and western Wisconsin. For more information, please visit mplsheart.org.
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TriClip™ and TRILUMINATE™ are trademarks of Abbott.
"New Treatment Could Help Fix the Heart’s ‘Forgotten Valve’" published by The New York Times