Journal of cardiac failure
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Multicenter Study Clinical Trial
Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial.
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 Heart Failure) trial will evaluate the safety and performance of the Interatrial Shunt Device (IASD) System II, designed to directly reduce elevated left atrial pressure, in patients with HFpEF. ⋯ Reduce LAP-HF is the first trial intended to lower left atrial pressure in HFpEF by means of creating a permanent shunt through the atrial septum with the use of a device. Although the trial is primarily designed to study safety and device performance, we also test the pathophysiologic hypothesis that reduction of left atrial pressure will improve symptoms and quality of life in patients with HFpEF.
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Venous congestion is common in patients with chronic heart failure (HF). We used a pocket-sized ultrasound imaging device (PID) to assess the patients' congestive status and related our findings to prognosis. ⋯ With the use of a handheld ultrasound device, signs of pulmonary congestion could be demonstrated. When found, these had a significant prognostic impact in clinically stable HF.