ANN ARBOR — St. Joseph Mercy Ann Arbor Wednesday announced participation in Parachute IV, a randomized pivotal 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, M.D., 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 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.
More at http://www.stjoeshealth.org.