News | Heart Failure | March 29, 2018

Abbott Initiates GUIDE-HF Trial for Improved Outcomes With CardioMEMS Monitor

New study will evaluate whether treatment with FDA-approved heart failure monitor improves survival and outcomes for NYHA Class II-IV heart failure patients

Abbott Initiates GUIDE-HF Trial for Improved Outcomes With CardioMEMS Monitor

March 29, 2018 — Abbott announced the company has initiated the landmark GUIDE-HF clinical trial using the CardioMEMS HF System. The GUIDE-HF trial will study whether the CardioMEMS device can improve survival and quality of life for people living with New York Heart Association (NYHA) Class II - IV heart failure.

The system has already been proven, when managed by a physician, to significantly reduce heart failure hospital admissions and improve the quality of life for people living with NYHA Class III heart failure. Doctors use the NYHA classification system to classify heart failure according to the severity of a person's symptoms.

"Monitoring pulmonary artery pressure with Abbott's CardioMEMS device has already been shown to offer improvements in patient care. We now want to build a stronger body of clinical evidence, with GUIDE-HF, that establishes its role in improving patient survival," said JoAnn Lindenfeld, M.D., primary investigator for the GUIDE-HF trial and director of advanced heart failure at Vanderbilt University Medical Center in Nashville.

The prospective trial will enroll 3,600 patients at 140 hospitals across North America with stage C, NYHA Class II-IV heart failure with either elevated brain-type natriuretic peptide (BNP) levels or prior heart failure hospitalizations in the past 12 months.

First implants for the trial occurred recently at:

  • Providence Hospital, Southfield, Mich., by Marcel Zughaib, M.D., and Herman Kado, M.D.;
  • Sanford Medical Center, Sioux Falls, S.D., by Orvar Jonsson, M.D.; and
  • Austin Heart, Austin, Texas by Kunjan Bhatt, M.D.

The GUIDE-HF trial is designed to build on the clinical experience gained from the CHAMPION trial and aims to provide additional clinical evidence to further expand coverage for this first-of-its-kind technology.

For people living with heart failure, changes in the pressure of blood through the pulmonary artery can indicate worsening heart failure — even before symptoms such as shortness of breath or weight gain are reported. Abbott's CardioMEMS HF System allows physicians to remotely monitor pressure changes before the patient's symptoms progress. This personalized approach allows physicians to more proactively manage a patient's care while reducing the likelihood of hospitalization.

The CardioMEMS HF System features a small pressure-sensing device, no larger than the size of a small paperclip, that is implanted through a minimally invasive procedure, directly into the patient's pulmonary artery. While at home, patients lay on a special pillow to wirelessly take a pressure reading. Data from the sensor is collected through radio frequency to the pillow's antenna and then is sent wirelessly to the patient's doctor. This information can then be used by physicians to proactively adjust medications and treatment plans, if needed.

For more information: www.sjm.com

Related CardioMEMS Content

New CardioMEMS Data Shows Effectiveness in Reducing Heart Failure Readmissions

CardioMEMS HF System Added to European Guidelines for Heart Failure Patients

VIDEO: Technologies to Reduce Heart Failure Readmissions

 

 

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init