Last updated on August 2019

Hemodynamic-GUIDEd Management of Heart Failure


Brief description 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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03387813

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Vidant Medical Center

Greenville, NC United States
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