Greece resident is the first U.S. patient in a groundbreaking heart failure therapy clinical trial
Rochester General Hospital (RGH) is the first U.S. site of a groundbreaking pivotal clinical trial of the AquaPass, a system designed to significantly help congestive heart failure and end-stage renal disease patients suffering from fluid overload.
Greece resident William Licherdell was the first patient in the U.S. to wear the AquaPass suit for congestive heart failure under the supervision of RRH cardiologist and heart failure specialist Scott Feitell, D.O., RRH Director of Heart Failure at Sands-Constellation Heart Institute. Dr. Feitell has been named Principal Investigator (PI) for the trial in the United States.
“We are excited at Rochester Regional Health to work on a clinical trial that could one day offer all of our heart failure patients a non-invasive renal independent therapy focused on improving their quality of life. We’re proud to be a part of the process driving innovation, and offering cutting-edge technology that could provide new hope for those trying to manage the symptoms of their disease,” said Dr. Feitell.
Fluid overload is the leading cause of hospitalization for congestive heart failure patients. Their hearts cannot pump blood effectively, causing increased pressure in the blood vessels leading to swelling in the legs, feet, hands and abdomen. Additionally, fluid buildup in the lungs causes shortness of breath. Not only is the retention of fluid uncomfortable for patients, it can become a life-threatening condition.
The AquaPass, which has received an FDA Breakthrough Device Designation, is a non-invasive, renal independent, drug free solution for treating fluid overload. It is worn as a robe and uses warm air to evaporate and remove fluid through the skin without significantly increasing body temperature.
If successful, the AquaPass could one day become a cost-effective way to treat a heart failure patient’s fluid overload symptoms from the comfort of their own homes, avoiding expensive and lengthy hospital stays.
Clinical trials conducted in Israel showed a weight reduction of fluid in all of the participating patients, a 30% decrease in diuretic drug use for those patients, nearly half of patients reported an improvement in their quality of life and none had a hospital readmission during the time of the testing.
A study of the AquaPass system toward FDA market approval in the U.S. is currently underway at RGH and still enrolling patients.
To learn more search at http://www.clinicaltrials.gov.
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