NCT03387813

Hemodynamic-GUIDEd Management of Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,358 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	CardioMEMS™ HF System	The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.

Timeline

• Start date: 2018-03-15
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2018-01-02
• Last updated: 2025-08-07
• Results posted: 2025-08-07

Locations

129 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study