Minneapolis – The Minneapolis Heart Institute Foundation® (MHIF), an internationally renowned cardiovascular research organization, announced today it is the first site in Minnesota to enroll a patient in the EXPAND II Pivotal Trial, a global, randomized clinical study evaluating the self-expanding, supra-annular Evolut™ TAVR (transcatheter aortic valve replacement) platform in patients with moderate, symptomatic aortic stenosis (AS), a population outside of current guidelines and indications for TAVR. The first patient enrolled in the study at MHIF was treated by the heart team led by Dr. Paul Sorajja, Roger L. and Lynn C. Headrick Family Chair for the MHIF Valve Science Center. Dr. Sorajja is the global principal investigator for the EXPAND II pivotal trial, providing direction and guidance to the study design and execution for all participating centers.
“I am excited to be among the first to enroll a patient in the EXPAND II Pivotal Trial because it represents an opportunity to follow our commitment to advancing care for patients who are living with heart valve disease,” said Dr. Sorajja. “This research is designed to further understand the role of an option like TAVR as a less invasive option for heart valve patients potentially before their symptoms become debilitating. We’re proud to continue contributing so that more patients can have advanced options earlier in the course of their disease.”
More than two million patients live with moderate AS in the U.S., which represents more than five times the population of patients with severe AS. TAVR is not currently included in the treatment guidelines for moderate AS; however, this study supports future expansion of indications for the Evolut TAVR platform. The current recommended management of patients with moderate AS includes periodic monitoring with transthoracic echocardiography every 1-2 years (or with any change in symptoms or findings).
“Significant experience exists today with TAVR procedures, and the benefits and risks are well studied in patients with advanced valve disease that leads to heart failure,” said Peter Eckman, MD, cardiologist and researcher at MHIF. “We now have the opportunity to study and understand the use of the technology as an option for patients before heart failure symptoms progress.”
The EXPAND II pivotal trial will enroll up to 650 patients at up to 100 sites globally and will include two co-primary endpoints to evaluate the safety and efficacy of the Evolut TAVR system with follow up out to ten years. For more information, visit ClinicalTrials.gov (NCT05149755). The study will evaluate for the first time the Medtronic Evolut™ PRO+ TAVR System and guideline-directed management and therapy (GDMT) compared to GDMT alone in patients with moderate, symptomatic AS.
The Evolut TAVR platform, which includes the Evolut™ R, Evolut™ PRO, Evolut™ PRO+, and newest-generation Evolut™ FX valves, is indicated for the treatment of symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the U.S.
About the MHIF Valve Science Center
The Minneapolis Heart Institute Foundation® (MHIF) leads the world in minimally invasive, heart valve repair and replacement, including a history of first-in-the-world applications. These technologies repair and replace diseased heart valves - aortic, mitral, pulmonary, and tricuspid – through peripheral vessels or small incisions. The MHIF Valve Science Center is a multi-disciplinary team of world-renowned physicians across multiple specialties, including interventional cardiologists, advanced imaging specialists, specialty nurses, research scholars and cardiac surgeons.
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 for patients around the world, including through the development of protocols like Level One, which continues to significantly improve outcomes and survival for heart attack 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.
MHIF’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.
# # #
