Published on January 10, 2020

ProHealth Care joins nation’s largest clinical trial for heart failure device

ProHealth Care has enrolled its first patient in a landmark national clinical trial aimed at improving care for those with heart failure. The trial will evaluate improved survival and quality of life with use of the CardioMEMS heart failure system earlier in disease progression.

Heart failure clinical trialHeart failure is the leading cause of hospitalization for Americans older than 65. Nearly 6 million Americans have heart failure, and 900,000 new patients are diagnosed each year, the American Heart Association reports.

CardioMEMS relies on an implantable device that allows the heart care team to remotely monitor patients. The device is part of cutting-edge technology designed to monitor pulmonary artery pressure changes and detect worsening heart failure before symptoms become noticeable to patients. With daily monitoring, doctors can easily adjust patients’ medications and help them avoid hospitalizations.

 “If this study shows that earlier implantation helps to reduce hospitalization and disease progression, it will be a big positive for heart failure patients around the country,” said cardiothoracic surgeon Thomas Wozniak, MD, ProHealth Care’s vice president of specialty care. “ProHealth’s inclusion in the clinical trial allows us to offer this therapy to a broader range of patients when they qualify for the trial.”

The CardioMEMS heart failure system has been available to patients at ProHealth Waukesha Memorial Hospital since 2015. CardioMEMS patients undergo a nonsurgical procedure that permanently places a miniaturized wireless monitoring device in the pulmonary artery. When patients return home, they rest for a few minutes each day on a CardioMEMS pillow that takes pressure readings. The pillow encases an antenna that sends the sensor readings to a secure database through a small electronic unit. Patients cannot feel the dime-sized sensor or the readings being taken. The implantable device does not rely on a battery.

The clinical trial is being led by ProHealth cardiologist Matthew Weinberg, MD. ProHealth plans to include more patients who meet trial guidelines in the national trial.

“ProHealth will continue to include patients in the trial until it has accepted the maximum number of participants,” Dr. Wozniak said. “The hope is that this study will make CardioMEMS applicable to a broader range of patients around the country.”

The GUIDE-HF Abbott CardioMEMS Heart Failure System clinical trial is the largest heart failure medical device trial in the U.S. The trial began in March 2018 and will continue through 2023. Participating health care centers undergo a rigorous evaluation process prior to acceptance. ProHealth is the second health care system in Wisconsin to be included in the trial.

The trial will enroll more than 3,600 patients at 140 hospitals across the nation. If it is successful, the study will expand coverage to a larger group of at-risk heart failure patients – allowing qualified patients to receive the device earlier in the progression of their disease.

Patients with heart failure are frequently hospitalized, have a reduced quality of life and face a higher risk of death. The Centers for Disease Control and Prevention says that half of heart failure patients die within five years of diagnosis.

For more information about clinical trials, visit ProHealthCare.org/ClinicalTrials.

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