Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance
Admitted to the hospital with a primary diagnosis of ADHF
Clinical signs and/or symptoms of congestion defined as at least one of the following: dyspnea at rest or with minimal exertion, orthopnea, lower extremity edema (≥2+), elevated jugular venous pressure, pulmonary rales, pulmonary vascular congestion on chest x-ray, pleural effusion or ascites
Projected need by the treating clinician for continued treatment with IV diuretic agents for more than 48 hours with the goal of significant fluid removal (more than 1L net fluid loss/24h)
Furosemide 40mg IV bid or equivalent
ADHF related to acute secondary disease (i.e., infection or acute coronary syndrome)
Treatment with high dose inotropes (milrinone ≥0.375 mcg/kg/min, dobutamine ≥5mcg/kg/min or dopamine ≥5mcg/kg/min) and/or treatment with vasopressors to maintain a systolic arterial blood pressure ≥90 mmHg or mean arterial blood pressure ≥60 mmHg
Current or previous support with a durable left ventricular assist device (LVAD) at any time or use of an extracorporeal membrane oxygenation (ECMO), percutaneous ventricular assist devices, intra-aortic balloon pump or patient on home inotropes currently or within the last 30 days
Recent myocardial infarction, percutaneous coronary intervention or surgical revascularization (within the last 30 days) or awaiting planned coronary intervention or surgery
Single group
ModulHeart Support
DeviceThe ModulHeart device will be implanted in the descending abdominal aorta.
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)
Technical success defined as successful device deployment, ability to deliver the treatment and remove the device
Assisted decongestion success defined as increase in the average hourly rate of urine output during the first 24 hours of ModulHeart-assisted decongestive therapy compared to the last 24 hours of diuretic therapy prior to pump implant
Change in urine output
Change in net fluid loss
Change in natriuresis
Change in creatinine clearance
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