Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial.

摘要: Abstract Objective Heart failure with preserved ejection fraction (HFpEF) is characterized by elevated left atrial pressure during rest and/or exercise. The Reduce LAP-HF (Reduce Elevated Left Atrial Pressure in Patients With Failure) trial will evaluate the safety and performance of Interatrial Shunt Device (IASD) System II, designed to directly reduce pressure, patients HFpEF. Methods Trial a prospective, nonrandomized, open-label novel device that creates small permanent shunt at level atria. A minimum 60 ≥40% New York Association functional class III or IV heart pulmonary capillary wedge (PCWP) ≥15 mm Hg ≥25 supine bike exercise be implanted an IASD followed for 6 months assess primary secondary end points. Safety standard clinical follow-up continue through 3 years after implantation. Primary outcome measures are periprocedural 6-month major adverse cardiac cerebrovascular events (MACCE) systemic embolic (excluding thromboembolism). MACCE include death, stroke, myocardial infarction, requirement implant removal. success implantation, reduction PCWP exercise, demonstration left-to-right flow device. Key points tolerance, quality life, incidence hospitalization. Conclusion first intended lower HFpEF means creating septum use Although primarily study performance, we also test pathophysiologic hypothesis improve symptoms life