Abbott has launched a clinical trial to evaluate the ability of its CardioMEMS HF System to improve survival and quality of life in patients with New York Heart Association (NYHA) Class II – IV heart failure.
The system includes a small pressure-sensing device that can be directly implanted, during a minimally invasive procedure, into the pulmonary artery.
It is designed to enable remote, wireless monitoring of blood pressure changes before the progression of symptoms. Data captured by the device is expected to help physicians to proactively manage medications and treatment plans for patients.
The prospective GUIDE-HF trial is set to recruit 3,600 volunteers at 140 North American hospitals.
Enrolment criterion for the trial is stage C, NYHA Class II-IV heart failure patients with enhanced brain-type natriuretic peptide (BNP) levels or previous heart failure hospitalisations over the past 12 months.
Abbott Heart Failure business divisional vice-president and medical director Philip Adamson said: “Data suggests that proactively managing people living with heart failure may change the course of the disease’s progression.
“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.”
Previously, the CardioMEMS HF System was reported to have significantly decreased hospital admissions due to heart failure and enhanced the quality of life for people with NYHA Class III heart failure.