GUIDE-HF Trial Evaluates Improvement in Survival and Outcomes With Abbott's CardioMEMS Monitor
April 2, 2018—Abbott Vascular announced the initiation of the GUIDE-HF clinical trial that will study whether the company's implantable CardioMEMS pressure-sensing device can improve survival and quality of life for patients living with New York Heart Association (NYHA) class II–IV heart failure (HF).
The prospective trial will be composed of 3,600 patients with stage C, NYHA class II–IV HF and either elevated brain-type natriuretic peptide levels or prior HF hospitalizations in the past 12 months. Patients will be enrolled at 140 hospitals across North America. 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 the CardioMEMS technology.
The CardioMEMS HF system, when managed by a physician, has demonstrated significant reduction in HF hospital admissions and improvement in quality of life for people living with NYHA class III HF.
JoAnn Lindenfeld, MD, who serves as primary investigator for the GUIDE-HF trial, commented in the company's announcement, "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." Dr. Lindenfeld is Director of Advanced Heart Failure at Vanderbilt University Medical Center in Nashville, Tennessee.