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Hemodynamic-GUIDEd Management of Heart Failure

NCT03387813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2358

Last updated 2025-08-07

Study results available
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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.

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

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Nessa Johnson, PhD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387813 on ClinicalTrials.gov