DRAIN HF Study

Description

Purpose

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and are resistant to diuretic therapy.

Description

The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care medical therapy in patients hospitalized with acute decompensated heart failure (ADHF) and persistent congestion despite usual medical management. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management. Randomization will be stratified by ejection fraction..

An additional registry arm will enroll participants who are considered candidates for advanced therapies in the near-term but need improvement in their renal function to be able to receive additional medical therapies. All eligible enrolled registry subjects will receive Aortix system support.

Planned study population is male or female patients 21 years of age or greater, with acute decompensated heart failure and diuretic resistance who remain congested despite standard of care medical therapy.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF).
Urine output for 12 hours prior to enrollment is < 1500 ml following at least 48 hours of the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated.
Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema or ascites after treatment with IV diuretics per inclusion criterion 2.
Age >21 years and able to provide written informed consent.
Negative pregnancy test if patient is of child-bearing potential.