MHIF Enrolls the First-in-the-World Patient in Clinical Trial of Minimally Invasive Clip-Based Repair System for Leaky Tricuspid Heart Valves
First-Ever Application of Treatment for Tricuspid Heart Valve Disease
MINNEAPOLIS, MN, August 9, 2017 – Minneapolis Heart Institute Foundation® announced it has enrolled the first-in-the-world patient in a clinical study to evaluate a minimally invasive clip-based repair system made by Abbott (a company based near Chicago), for treating people with moderate or severe tricuspid regurgitation (TR), a common condition affecting the right side of the heart. This study is the first application of this minimally invasive technology for use in the tricuspid heart valve, where currently there are no options for most patients. Dr. Paul Sorajja performed this first-in-human procedure at Minneapolis Heart Institute® at Abbott Northwestern Hospital.
Tricuspid regurgitation is leakage of blood backwards into the right atrium through the tricuspid valve each time the right ventricle contracts. The increased volume of blood in the right atrium can cause it to enlarge, which can change the pressure in the nearby chambers and blood vessels. Currently there are no commercially available minimally invasive treatment options for people with moderate or severe TR and these patients face a poor prognosis.
The study, called TRILUMINATE, is a prospective, single-arm, multi-center study designed to evaluate the performance of clip-based technology in approximately 75 symptomatic patients at 25 sites across the U.S. and Europe. The primary endpoints are an echocardiographic tricuspid regurgitation reduction of ≥ 1 grade at 30 days post-procedure, and the assessment of major adverse events at six months.
“Patients who have tricuspid regurgitation (TR) have limited options for treatment. Current guidelines recommend medical therapies or invasive surgical options to treat this disease,” said Paul Sorajja, MD, Director of the MHIF Valve Science Center and investigator in the TRILUMINATE study. “Since less invasive approaches are currently unavailable to treat TR, patients who meet these study criteria and are enrolled will have access to this innovative technology. The opportunity for MHIF to provide the first-in-the-world implant is unprecedented. The core mission of MHIF’s Valve Science Center is to improve the health of patients with valvular heart disease through clinical research, innovation, and education. Through a multidisciplinary approach, MHIF continues to provide first-in-human trials that improve patient options and change cardiology care worldwide.”
About the 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 research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 175 peer-reviewed abstracts. Cardiologists, hospitals and communities around the world adopt MHIF protocols to save lives, improve care and create healthier living opportunities.
- Education and Outreach — MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes. And, MHIF leads cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health.
The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and supports research initiatives of Minneapolis Heart Institute® at Abbott Northwestern Hospital. Minneapolis Heart Institute® physicians provide care for patients at Abbott Northwestern Hospital in Minneapolis and at 38 community sites across Minnesota and western Wisconsin.