Norman Mangner, MD, offers his presentation “The Road to Class I: Updates from PROTECT IV” as the final presentation in the TCT 2023 symposium, “Safeguarding the Heart: Defining HRPCI.” He reviews the PROTECT IV study design and primary objectives and highlights the right heart catheterization substudy, renal substudy, viability substudy and proteomics/biobanking substudy. He provides an update on the active sites in the United States and Europe, noting that as of TCT 2023, enrollment was approximately 60% complete and ongoing. He concludes by stating, “I think PROTECT IV is the road to a Class I indication for PCI with Impella MCS in CHIP patients.”

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