Abbott Laboratories started enrollment for its GUIDE-HF trial of the Cardiomems HF system to determine if the device can improve survival and quality of life among class II through IV heart failure (HF) patients based on the New York Heart Association classification system. Cardiomems HF already was FDA-approved to treat patients with class III HF, to reduce hospital admissions and increase quality of life.
"The GUIDE-HF trial aims to expand the indication to people living with NYHA Class II and IV heart failure," Justin Paquette, director of public affairs, Neuromodulation Division, Cardiac Arrhythmias & Heart Failure Division, Abbott, told BioWorld MedTech. "Additionally, the study aims to build on previous clinical evidence to further expand coverage for this new HF technology."
The Cardiomems HF system monitors pressure within the pulmonary artery and provides information to physicians remotely, allowing them to continually manage the disease and reduce poor outcomes and hospitalization. Blood pressure changes in the pulmonary artery can be a sign of disease that is progressing. HF, which affects more than 26 million people worldwide, includes symptoms of shortness of breath and weight gain.
HF continues to impact
"Despite medical advances, hospitalization for HF is a worsening epidemic," said Paquette. More than 8 million patients will have HF in the U.S. by 2030, according to the American Heart Association. That growing patient population "will drive hospital visits to 3 million per year. Data shows that proactively managing people living with HF may change the course of the disease's progression. That's what makes this technology unique – it's the first-of-its-kind approach to redefine HF management."
Philip Adamson, divisional vice president and medical director of Abbott's Heart Failure business, Abbott added, "Data suggests that proactively managing people living with HF may change the course of the disease's progression. The Cardiomems HF system is the first-of-its-kind approach to redefine HF management. The GUIDE-HF study sets out to make this technology available to an expanded group of people who could benefit from it."
The Cardiomems HF system is made up of a minimally invasive implant, which is a paperclip-sized sensor to detect pressure, and a pillow embedded with an antenna to pick up radiofrequency data and wirelessly transmit the information to the care team. A patient's physician can then adjust medication or make changes to manage HF.
The Abbott Park, Ill.-based company's trial will enroll 3,600 patients with stage C, class II to IV HF with elevated brain-type natriuretic peptide levels or hospitalization for previous HF in the past year. The study will be conducted across 140 U.S. centers. Patients have thus far received the implants at Austin Heart in Texas, Providence Hospital in Michigan and Sanford Medical Center in South Dakota. GUIDE-HF follows the earlier CHAMPION study, and intends to expand application of the technology.
Competitors Medtronic plc, of Dublin, and Marlborough, Mass.-based Boston Scientific Corp. also offer HF devices. Medtronic plc won an expanded FDA approval for pacemakers and defibrillators for biventricular pacing devices for patients with atrioventricular block and class I-III heart failure several years ago. That clearance was based on the company's Block HF trial of 691 patients who received three lead cardiac resynchronization therapy devices programmed for appropriate pacing. Across an average of three years, the biventricular group reported a 26 percent decrease in all-cause mortality, which was the primary endpoint along with emergency care for HF, and a 15 percent or less spike in LV end-systolic volume index. The expanded indication included the Consulta and Syncra portfolio of devices. (See BioWorld MedTech, April 14, 2014.)
Boston Scientific won FDA approval for a high-voltage and MRI-safe label for its Resonate family of implantable cardiac resynchronization therapy defibrillator and cardioverter defibrillator. The MRI label was approved three months ahead of expectations, and were tied to its ENABLE MRI trial with 500 patients. (See BioWorld MedTech, Sept. 26, 2017.)
Boston Scientific also markets the Heartlogic Diagnostic device, which can notify doctors of HF that is worsening based on breathing rate and volume, heart sounds, thoracic impedance, heart rate and heart activity. Data around the device suggests it can provide indication of HF events at an average of 34 days in advance. (See BioWorld MedTech, Sept. 26, 2017.)
Abbott also won FDA approval for MRI safety with its Ellipse ICD and its high-voltage leads. (See BioWorld MedTech, Sept. 25, 2017.)