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66) and patients with left-ventricular ejection fraction (LVEF) 40% or ≤ 40% (p for interaction=0.21). At 12 months, HRQoL improved by 17.7 points (95% CI 10.8 to 24.6) and pulmonary capillary wedge pressure (PCWP) decreased by 2.0 mmHg (95% CI -3.6 to -0.4), respectively. There were no changes in LVEF or NT-proBNP during follow-up. Shunt patency ranged from 50% for the first-generation v-Wave to 100% for the Corvia IASD II and the second-generation v-Wave system. The summary risk of serious adverse device-related effects was 8% (95% CI 1 to 2