Hemodynamic-GUIDEd Management of Heart Failure — GUIDE-HF  

Heart Failure Clinical Trial

Official title: Hemodynamic-GUIDEd Management of Heart Failure

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV
• Heart Failure With Normal Ejection Fraction
• Heart Failure With Reduced Ejection Fraction
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Heart Failure,Congestive
• Heart Failure; With Decompensation

• NCT number: NCT03387813
• Study type: Interventional
• Source: Abbott Medical Devices
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Completion date: May 17, 2023