Hemodynamic-GUIDEd Management of Heart Failure

Conditions

• 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; With Decompensation
• Heart Failure，Congestive

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CardioMEMS™ HF System — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Mar 15, 2018

Status verified

Jul 2025

Primary completion

May 17, 2023

Completion

May 17, 2023

Study Design

Enrollment

2,358 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Randomized Arm - Treatment Group
  Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
• Experimental: Randomized Arm - Control Group
  Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
• Experimental: Single Arm
  Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.

Primary Outcome Measure

(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [ Time Frame: 12 months post-implantation (395 days after implant date) ]

Locations (125)

Find similar trials in Phoenix, AZ

Related Studies

• Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
  Recruiting · Medtronic · Birmingham, Alabama
• Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure
  Recruiting · UConn Health · Farmington, Connecticut
• Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
  Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
• Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
  Recruiting · Arunark Kolipaka · Columbus, Ohio