St. Joseph Mercy Ann Arbor to participate in landmark study for heart failure in U.S.
St. Joseph Mercy Ann Arbor to participate in landmark study of first-of-its-kind treatment for heart failure in U.S.
ANN ARBOR, Mich. – (March 19, 2013) - St. Joseph Mercy Ann Arbor today announced participation in PARACHUTE IV, a randomized pivotal U.S. trial of the minimally invasive catheter-based Parachute™ Ventricular Partitioning Device for the treatment of heart failure.
The first-of-its-kind Parachute Ventricular Partitioning Device is a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
Through a small catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. This minimally invasive procedure is performed in the catheterization laboratory under conscious sedation
This simple, lower risk procedure will benefit certain patients and better treat their chronic heart failure, according to Arthur Szyniszewski, MD, a cardiologist at St. Joseph Mercy Ann Arbor.
“Previously these patients needed open heart surgery, but this procedure can be done through a puncture in the groin without needing any stitches or general anesthesia,” said Szyniszewski. “The patient can go home the following morning versus a weeklong hospital stay.”
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. More than 20 million people around the world are affected, with approximately six million in the United States, where it is responsible for 1.1 million hospitalizations annually.
Szyniszewski hopes that better heart function will impact patients’ chronic difficulty with shortness of breathe, lack of stamina, and decreased energy to improve their quality of life and possibly require less need for diuretics or other medications.
St. Joseph Mercy is currently accepting patients with previous anterior wall myocardial infarction with class 3 heart failure. If you would like to be considered to participate in the study, contact Michigan Heart at 734-712-8000.
“There is a significant unmet need for better treatments for patients in the United States who have had a heart attack and are facing an extremely poor quality of life due to the debilitating symptoms of heart failure, including shortness of breath, fatigue, lack of appetite, impaired thinking, and increased heart rate,” said William T. Abraham, M.D., the principal investigator of the trial and director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center.
“Based on positive three-year data shown earlier this year, I believe that the innovative Parachute device could provide new hope for many of the 20 million patients around the world with heart failure. I look forward to the results of this landmark study.”
PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 500 patients with ischemic heart failure at up to 65 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.
# # #
About Saint Joseph Mercy Health System
Saint Joseph Mercy Health System (SJMHS) is a health care organization serving six counties in southeast Michigan including Livingston, Macomb, Oakland, St. Clair, Washtenaw and Wayne. It includes 537-bed St. Joseph Mercy Ann Arbor, 443-bed St. Joseph Mercy Oakland in Pontiac, 304-bed St. Mary Mercy Livonia, 136-bed St. Joseph Mercy Livingston in Howell, 119-bed St. Joseph Mercy Port Huron and 113-bed Chelsea Community Hospital. Combined, the six hospitals are licensed for 1,726 beds, have six outpatient health centers, four urgent care facilities, more than 25 specialty centers; employ more than 14,000 individuals and have a medical staff of nearly 2,700 physicians.
A member of Trinity Health, the nation’s fourth largest Catholic health care organization, SJMHS is committed improving the health of its communities by reinvesting its profits back into the community through new technologies, vital health services, and access for all. The hospitals of SJMHS provide approximately $100 million in community benefit to the communities it serves each year.
For more information on health services offered at Saint Joseph Mercy Health System, please visit www.stjoeshealth.org.