Minneapolis Heart Institute Foundation® (MHIF) today announced an important research milestone with the U.S. Food and Drug Administration (FDA) approval of the TriClip™ (manufactured by Abbott), a first-of-its-kind, non-surgical, transcatheter edge-to-edge repair (TEER) system. MHIF was the top enroller (enrolling the first and largest number of patients) of all 68 clinical sites participating in the TRILUMINATE™ Pivotal 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 an early research study in 2017 and completed the first-in-the-world enrollment in the pivotal trial in August 2019.
"We are proud to be the leading center contributing significant research to this important new treatment option for patients who are living with tricuspid regurgitation, a heart condition that negatively affects quality of life and puts them at grave rise of serious health issues,” said Paul Sorajja, MD, the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for MHIF, director of the Center for Valve and Structural Heart Disease for Allina Health Minneapolis Heart Institute®, and global principal investigator of the TRILUMINATE Pivotal trial. "We developed a depth of understanding and expertise in the use of the new repair technology. We celebrate this research milestone and the FDA approval, which expands access to an advanced treatment option backed by excellent safety and effectiveness to help restore tricuspid valve performance without high-risk open-heart surgery."
The MHIF Imaging Core Lab, led by João Cavalcante, MD, director of the Cardiovascular Imaging Research Center at MHIF, provided advanced cardiac imaging analysis for the TRILUMINATE Pivotal trial. The imaging sub-study was a novel assessment of the right side of the heart using cardiac CT and MRI before and after a tricuspid repair procedure. The imaging analysis demonstrated beneficial changes in the heart following tricuspid repair, consistent with the main findings of the trial.
The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart. TR can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, TR can lead to a poor quality-of-life, heart failure, and ultimately, death. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve the patients’ lives.
Delivered through a vein in the leg, TriClip's technology works by positioning together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. On average, people who receive TriClip need only one day in the hospital before they recover and can return home.
As part of its approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world's first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. In the study, 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.
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.
