A Study Comparing the Aortix Endovascular Device to Diuretics Alone for Treating Acute Heart Failure in Adults

What this Trial Is About

Researchers are evaluating the Aortix System, a circulatory support device, for patients with acute decompensated heart failure ADHF who have persistent congestion despite standard medical treatment. This study compares the safety and effectiveness of the Aortix device versus usual medical care in patients who are resistant to diuretics, regardless of their hearts ejection fraction. The trial includes a randomized group and an additional registry arm for patients needing improved kidney function before advanced therapies. Participants will be randomized in a 21 ratio to receive either the Aortix device or standard care based on a diuretic treatment algorithm. Those in the registry arm will receive support from the Aortix system. The study will enroll up to 320 patients across multiple sites, with the randomized portion including up to 240 participants and 80 in the registry. Treatment involves device placement and medical management during hospitalization for heart failure. Throughout the study, participants will be closely monitored for safety events and treatment effectiveness over 30 days. Key assessments include fluid loss, survival, heart failure rehospitalizations, kidney function, and patient symptoms such as breathlessness. Follow-up visits and evaluations will occur to track adverse events, biomarker levels, body weight, and other clinical measures to understand how well the device supports heart failure management.

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure