Abbott Begins Trial to Assess Boosted Survival & Outcomes with CardioMEMS Monitor

Abbott announced the company has initiated the landmark GUIDE-HF clinical trial using the CardioMEMS HF System. The GUIDE-HF trial will study whether the CardioMEMS device can improve survival and quality of life for people living with New York Heart Association (NYHA) Class II—IV heart failure. The CardioMEMS HF System has already been proven, when managed by a physician, to significantly reduce heart failure hospital admissions and improve the quality of life for people living with NYHA Class III heart failure. Doctors use the NYHA classification system to classify heart failure according to the severity of a person’s symptoms.
 
“Monitoring pulmonary artery pressure with Abbott’s CardioMEMS device has already been shown to offer improvements in patient care. We now want to build a stronger body of clinical evidence, with GUIDE-HF, that establishes its role in improving patient survival,” said JoAnn Lindenfeld, M.D., primary investigator for the GUIDE-HF trial and director of advanced heart failure at Vanderbilt University Medical Center in Nashville.
 
The prospective trial will enroll 3,600 patients at 140 hospitals across North America with stage C, New York Heart Association (NYHA) Class II-IV heart failure with either elevated brain-type natriuretic peptide (BNP) levels or prior heart failure hospitalizations in the past 12 months. More information on the trial is available at clinicaltrials.gov.
 
“Data suggests that proactively managing people living with heart failure may change the course of the disease’s progression,” said Philip B. Adamson, M.D., divisional vice president and medical director of Abbott’s Heart Failure business. “The CardioMEMS HF System is the first-of-its-kind approach to redefine heart failure management. The GUIDE-HF study sets out to make this technology available to an expanded group of people who could benefit from it.”
First implants for the trial occurred recently at:
 

• Providence Hospital, Southfield, Mich. by Drs. Marcel Zughaib, and Herman Kado
• Sanford Medical Center, Sioux Falls, S.D. by Dr. Orvar Jonsson
• Austin Heart, Austin, Texas by Dr. Kunjan Bhatt