This study establishes a safety and feasibility endpoint for creating an atrial septal defect to help offload left atrial pressure in heart failure patients with both reduced and preserved ejection fraction. The Allegiant device creates a 7mm ASD with electrocautery and leaves no hardware behind. The ASD was durable and present several months after the index procedure. Patients who received the iatrogenic ASD had lower Pulmonary pressures with exercise testing and an improvement in quality of life. In order to recommend this study in heart failure patients, there will likely need to be a randomized sham procedure study.
All editors: Brian C. Kolski, MD
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