Saint Thomas Heart First Cardiac Program Awarded U.S. TRANSFORM Trial in Middle Tennessee
Saint Thomas Heart is the only cardiac program in Middle Tennessee enrolling patients in the U.S. TRANSFORM trial, a new cardiac surgery clinical trial studying a new “sutureless” aortic valve prosthesis for patients in need of an aortic valve replacement. These procedures are unique because they require less sutures to implant the prosthetic aortic valve, thus decreasing surgery times and potentially resulting in better patient outcomes.
“The goals of this trial are to facilitate more rapid deployment of the replacement valve during surgery, which should decrease the time that the heart must be stopped, and to allow for easier implantation when using a minimally invasive approach,” said Evelio Rodriguez, MD, the principle investigator for the trial. “My hope is to offer patients a reliable option that leads to a faster recovery and an overall better experience.”
The award of this trial is another step forward for Saint Thomas Heart’s ever-growing valve program.
“Currently, only 26 medical centers across the country offer access to this procedure,” Dr. Rodriguez said. “Saint Thomas Health is proud of be one of them.”
The EDWARDS INTUITY Elite valve system is designed to be used during traditional open-heart aortic valve replacement procedures, as well as small incision procedures. Target patients include individuals diagnosed with aortic valve stenosis or aortic stenosis with aortic insufficiency.
Approximately 1.5 million people in the United States suffer from aortic stenosis, a progressive disease that affects the aortic heart valve. Aortic stenosis occurs when the aortic heart valve narrows or becomes obstructed as a result of calcium deposits and is unable to open and close properly. It may lead to symptoms that restrict activities such as walking even short distances or climbing the stairs. Severe aortic stenosis may weaken the heart muscle over time, increasing the risk of heart failure.
ABOUT THE U.S. TRANSFORM TRIAL
The U.S. TRANSFORM trial is a prospective, multi-center Investigational Device Exemption (ICE) trial that studies the safety of effectiveness of the EDWARDS INTUITY Elite valve systems for patients with aortic stenosis or stenosis-insufficiency in need of surgical aortic valve replacement (AVR). For more information about The TRANSFORM Trial, please visit www.clinicaltrials.gov.
ABOUT SAINT THOMAS HEALTH
Saint Thomas Health is Middle Tennessee’s faith-based, not-for-profit health care system united under the common mission of one healing community. With more than 7,000 associates, Saint Thomas Health is focused on transforming the health care experience and helping people live healthier lives, with special attention to the poor and vulnerable. The regional health system includes – Saint Thomas Hospital for Spinal Surgery, Saint Thomas Midtown Hospital and Saint Thomas West Hospital in Nashville, Saint Thomas Rutherford Hospital in Murfreesboro and Saint Thomas Hickman Hospital in Centerville – and a comprehensive network of affiliated joint ventures, medical practices, clinics and rehabilitation facilities. Saint Thomas Health is a member of Ascension Health, a Catholic organization that is the largest not-for-profit health system in the United States. For more information, visit www.sths.com.