The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.
The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF patients who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization.
The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.
The CardioMEMS HF System is made up of the PA pressure sensor itself, an external electronics measurement system and HF website called the Merlin.net™ Patient Care Network (PCN).
Males and Females
18 Years and older
Study Type: Interventional
View list of Trial sites on
The CardioMEMS HF System makes a significant difference in patients’ lives.
Proven to improve quality of life1,2, functional capacity1,2, decrease mortality4,5, HF hospitalization1,3 and reduce HF related hospitalization costs3.
In a commercial setting, PA pressure-guided therapy for HF:7
PA pressure-guided therapy is safe with few device/system related complications (0.3%) and a low rate of pressure sensor failure (0.1%).7 The CardioMEMS HF System is the ONLY heart failure management tool shown to be effective in HFpEF6.
The CardioMEMS HF System is a product of Abbott, formerly St. Jude Medical