HeartFlow Announces Enrollment of First Three Patients in FUSION Trial
Excerpt from the Press Release:
National Health Care Institute of the Netherlands-supported study to evaluate role of the HeartFlow Analysis in reducing unnecessary invasive procedures
REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced that physicians at Erasmus MC Hospital (Rotterdam NL) have enrolled the first three patients in the FUSION (Addition of FFRct in the diagnostic pathway of patients with stable chest pain to reduce unnecessary invasive coronary angiography) randomized controlled trial. The FUSION trial, which is supported by the National Health Care Institute of the Netherlands (subsidieregeling Veelbelovende zorg: Zorginstituut Nederland / ZonMw), will evaluate whether the use of the HeartFlow FFRct Analysis as part of a coronary diagnostic pathway is effective in reducing unnecessary invasive coronary angiograms (ICAs).
Each year, 180,000 patients in the Netherlands visit a cardiologist with complaints of chest pain.1 As part of the diagnostic pathway, patients typically receive a coronary computed tomography angiogram (CTA) to determine if there is a stenosis or narrowing in the coronary artery. The degree to which a narrowing is causing chest pain is not always clear from a coronary CTA alone and patients are often sent for an ICA. Over half of patients who undergo an ICA are found to have no coronary disease or only non-obstructive disease2, making the ICA unnecessary in retrospect.
“By combining the functional information provided by HeartFlow FFRct with the anatomical information from the coronary CTA, we will be better able to assess non-invasively which patients require further invasive investigation,” said Ricardo Budde, MD, PhD, Associate Professor and Principal Investigator of Cardiovascular Imaging, Erasmus MC Hospital. “With the FUSION trial, we anticipate a 33% reduction in unnecessary ICAs which we believe will lead to cost savings for the overall healthcare system.”
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