CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,358 enrolled
Drug / intervention
CardioMEMS™ HF Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03387813
NCT03387813N/ACompleted
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Hemodynamic-GUIDEd Management of Heart Failure

Abbott Medical Devices·interventional·Posted Jan 2, 2018·Updated Aug 7, 2025

In Brief

A clinical study evaluating CardioMEMS™ HF System for Heart Failure and 9 related conditions. Completed, enrolled 2,358 participants across 129 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart 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
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 2, 2018
Enrollment StartMar 15, 2018
Primary CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.5 years ago

Interventions

CardioMEMS™ HF Systemdevice

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.