The Miriam Hospital recruiting for clinical trial of device to treat heart failure

The Miriam Hospital is actively recruiting local participants for a U.S. clinical trial of the Parachute device for treating heart failure. The study is focused on determining if the new minimally invasive catheter-based device can slow the progression of heart failure, reduce repeat hospitalizations and death, and significantly improve quality of life for patients who experience enlargement of the left ventricle after a heart attack. The only site in Rhode Island to take part in the study, The Miriam has already completed the Parachute implant on two local patients. The Parachute device, an experimental treatment, is the first of its kind in the U.S.

"Presently, there are very few treatment options available for patients who experience enlargement of the left chamber of the heart, which makes this clinical trial crucial," said Paul Gordon, M.D., director of the cardiac catheterization laboratory at The Miriam Hospital and principal investigator of the trial at The Miriam Hospital. "Heart attack survivors currently suffering from heart failure may be candidates for the Parachute device research study and should discuss their condition with their physician."

Following a heart attack, many patients experience enlargement of the left ventricle causing heart failure symptoms such as shortness of breath. About 22 percent of men and 46 percent of women will develop heart failure within six years of having a heart attack. The Parachute device works by separating the damaged muscle from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its function. It is placed by an interventional specialist in the left chamber of the heart through a small catheter in the femoral artery. The minimally invasive procedure is performed in the catherization laboratory while a patient is awake but sedated and takes about 75 minutes.

The PARACHUTE IV randomized clinical trial explores the effectiveness of the device by comparing it to medical therapy and placement of an internal cardiac defibrillator (ICD) in approximately 500 patients with ischemic heart failure at up to 65 centers.

Heart disease is the leading cause of death for both men and women, according to the Centers for Disease Control and Prevention, killing about 610,000 people in the U.S. every year.