作者： Sanjiv J Shah , Ted Feldman , Mark J Ricciardi , Rami Kahwash , Scott Lilly
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摘要: OBJECTIVE To evaluate the 1-year safety and clinical outcomes of the IASD compared with a sham control treatment.DESIGN, SETTING, AND PARTICIPANTS This phase 2, double-blind, 1-to-1 sham-controlled multicenter RCT of IASD implantation vs a sham procedure (femoral venous access and imaging of the interatrial septum without IASD) was conducted in 22 centers in the United States, Europe, and Australia on patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, LVEF equal to or greater than 40%, exercise PCWP equal to or greater than 25 mm Hg, and PCWP-right atrial pressure gradient equal to or greater than 5 mm Hg.