Abbott (NYSE:ABT) said today it launched a new trial of its CardioMems HF implantable cardiac monitoring system, exploring the device’s ability to improve survival and quality of life for people with New York Heart Association Class II to Class IV heart failure.
The study, dubbed the Guide-HF trial, is slated to enroll a total of 3,600 patients at 140 hospitals across North America as the company looks to expand coverage for the device.
“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,” primary investigator Dr. JoAnn Lindenfeld of Nashville’s Vanderbilt University Medical Center said in a prepared statement.
The trial will examine patients with stage C, NYHA Class II-IV heart failure with either elevated brain-type natriuretic peptide levels or prior heart failure hospitalizations in the past 12 months, Abbott said.
The first patients have already been enrolled in the trial, Abbott said, with the first implants taking place at the Southfield, Mich.-based Providence Hospital by Dr. Marcel Zughaib and Dr. Herman Kado, at the Sioux Falls, S.D.-based Sanford Medical Center by Dr. Orvar Jonsson and at Austin’s Austin Heart by Dr. Kunjan Bhatt.
“Data suggests that proactively managing people living with heart failure may change the course of the disease’s progression. The CardioMEMS HF System is the first-of-its-kind approach to redefine heart failure management. The Guide-HF study sets out to make this technology available to an expanded group of people who could benefit from it,” Abbott heart failure biz medical director & divisional VP Dr. Philip Adamson said in a press release.
Earlier this month, Abbott said that it logged a reimbursement win in Japan for its MitraClip device for treating mitral valve regurgitation.