Shelley Hall, MD, FACC, FHFSA
Type of study:
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
“Heart failure is the leading cause for hospitalization in patients over age 65. Through research we have learned that signs of deterioration occur inside the body 2-3 weeks prior to the patient having symptoms that they can notice or report. The Cardiomems device could detect and record these early signs, transmit to the physician office and thus trigger medical interventions capable of potentially preventing clinical deterioration. This technology could provide future heart failure patients with a potential new tool in aiding their recovery,” says Shelley Hall, MD, principal investigator.
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 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 (HFH). 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.
Main/critical inclusion and exclusion criteria: A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT03387813?term=NCT03387813&rank=1
Horacio Martinez, BS, CCRC, Horacio.Martinez@BSWHealth.org, 214.820.0338.