New Clinical Trial at the Texas Heart Institute Explores Heart Failure Treatment After Heart Attack

Houston, TX – August 24, 2020– Heart disease is the leading cause of death in both women and men in the U.S. and it is responsible for about one in every four deaths, according to the Centers for Disease Control. In light of that, the Texas Heart Institute has commenced the ALIVE Trial for heart attack victims, studying the ability of a new therapy to improve heart failure symptoms, quality of life, and walking ability, and to prevent heart failure-related hospital stays.

 

The clinical study is investigating the LIVE™ (Less Invasive Ventricular Enhancement) Therapy, which does not require open-heart surgery. It is the first catheter-based procedure designed to close off the damaged portion of the heart caused by a previous heart attack so the healthy portion can pump better and send more blood and oxygen to the rest of the body. Improving the heart’s ability to pump blood has been linked to better heart function, quality of life, and life span.

 

The LIVE Therapy is designed for patients who have had a heart attack and now suffer from heart failure, and who continue to suffer from fatigue, shortness of breath, or physical limitations despite ongoing treatment.

 

“We are enthusiastic about the prospect of treating patients in a less invasive way that may help them avoid the pain, long recovery time, and complication risks that can come with open-heart surgery,” says Dr. Sam Sheth, Principal Investigator of the study.

 

Heart failure is a clinical condition in which the heart cannot pump enough blood to meet the metabolic demands of the body. The American Heart Association (AHA) estimates that one in five adults will develop heart failure after the age of 40. Heart failure is increasingly prevalent because of the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.

 

During heart failure progression, the heart loses its ability to respond to increased metabolic demand (such as during exercise) and, ultimately, cannot pump enough blood to meet the body’s needs even at rest. As a result, patients become bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years after the initial diagnosis.

 

Despite receiving guideline-directed medical therapies involving a wide range of pharmacologic, device, and surgical options, many patients deteriorate over time and develop advanced heart failure symptoms that cannot be effectively managed by existing medical therapies.

 

Current treatment options for patients whose heart failure continues to worsen include open-heart surgery for implantation of a left ventricular assist device (LVAD) or for heart transplantation. The LIVE Therapy is designed for patients who are not yet candidates for these treatments or who want a less invasive alternative.

 

“Participating in the ALIVE Trial enables us to be on the front lines of research into the most innovative therapies with the potential to help patients suffering from the limitations of heart failure,” says Emerson Perin MD, Ph.D., Medical Director of the Texas Heart Institute.

 

Texas Heart Institute has been at the forefront of cardiovascular discovery and innovation since its formation. Through clinical research studies and the patients who volunteer to participate in them, our investigators find answers to important questions about the prevention, diagnosis, and treatment of medical conditions.

 

Patients who have had a heart attack and continue to suffer from heart failure symptoms can contact the Texas Heart Institute Center for Clinical Research to find out whether they are a candidate for the ALIVE Trial at 832-355-9405, or email clinicalresearch@texasheart.org.

 


About Texas Heart Institute

The Texas Heart Institute (THI), founded in 1962 by world-renowned cardiovascular surgeon Dr. Denton A. Cooley, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education, and improved patient care. More information about THI (@Texas_Heart) is available at www.texasheart.org.

Media Contact:
Keri Sprung
ksprung@texasheart.org

 

ABOUT THE ALIVE TRIAL

The ALIVE Trial is a prospective, multi-center, dual-arm pivotal study for the LIVE™ (Less Invasive Ventricular Enhancement) Therapy using the Bioventrix Revivent TC™ Transcatheter Ventricular Enhancement System. The study encompasses 126 patients in multiple U.S. centers in a 2:1 study, comparing 84 patients treated with the investigational therapy with 42 patients in a control group receiving standard medical treatment. The results will be analyzed to determine whether LIVE Therapy improves heart failure symptoms, quality of life, and exercise capacity prevents hospital readmissions for heart failure, and is safe. Study subjects must have heart failure symptoms classified as NYHA Class III or higher, where they suffer from fatigue and shortness of breath even during light physical activity, with damage to their left ventricle, among other criteria.

 

ABOUT LIVE THERAPY

The LIVE Therapy is designed for patients who have had a heart attack and now suffer from heart failure, and who continue to suffer from fatigue, shortness of breath, or physical limitations despite ongoing treatment. The LIVE Therapy avoids open heart surgery and is the first catheter-based procedure designed to close off the damaged portion of the heart so the healthy portion can pump better and deliver more blood and oxygen to the rest of the body. Improving the heart’s ability to pump blood has been linked to better heart function, quality of life, and life span. In the procedure, micro-anchors are placed on either side of the damaged area of the heart and cinched together to close off that area, so the healthy portion of the heart can work more effectively. Previous studies of the LIVE Therapy have shown statistically significant patient improvement at two years across all key heart failure measures, including heart function, heart failure symptoms, exercise capacity, and quality of life, as well as improved survival and reduced rates of hospital readmission for heart failure. Current treatment options for patients whose heart failure continues to worsen include open-heart surgery for implantation of a left ventricular assist device (LVAD) or for heart transplantation.