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

News | Cardiovascular Clinical Studies

February 21, 2024 — An 80-year-old woman from Frankenmuth, Michigan is the first Henry Ford Health structural heart ...

Home February 21, 2024
Home
News | Cardiovascular Clinical Studies

February 15, 2024 — Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and ...

Home February 15, 2024
Home
News | Cardiovascular Clinical Studies

January 3, 2024 — Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce the completion of ...

Home January 03, 2024
Home
News | Cardiovascular Clinical Studies

December 19, 2023 — Peerbridge Health has announce the successful completion and findings of its prospective ...

Home December 19, 2023
Home
News | Cardiovascular Clinical Studies

December 14, 2023 — Published results of a large, national heart attack study show that patients with a life-threatening ...

Home December 14, 2023
Home
News | Cardiovascular Clinical Studies

December 11, 2023 — A world without cardiovascular disease (CVD) is possible, yet millions of lives are lost prematurely ...

Home December 11, 2023
Home
News | Cardiovascular Clinical Studies

December 8, 2023 — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac ...

Home December 08, 2023
Home
News | Cardiovascular Clinical Studies

November 29, 2023 — Inari Medical, Inc., a medical device company with a mission to treat and transform the lives of ...

Home November 29, 2023
Home
Subscribe Now