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Aortix System / Cardiorenal Syndrome / Heart Failure · Interventional Study
ClinicalTrials.gov · August 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered interventional trial comparing an Aortix endovascular circulatory support device against standard diuretic therapy in acute decompensated heart failure patients with diuretic resistance. The study is actively recruiting and has not yet reported results; no efficacy or safety data are available from this registry record.
Interventional, Randomized, Parallel, Open label, Treatment purpose. Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome, ADHF, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure; With Decompensation, Heart…; age from 21 Years. Intervention: Treatment Arm; Advanced HF Registry. Compared with: Control Arm — No Intervention. n = 320. 49 sites: United States, Hungary.
This is a registered interventional trial comparing an Aortix endovascular circulatory support device against standard diuretic therapy in acute decompensated heart failure patients with diuretic resistance. The study is actively recruiting and has not yet reported results; no efficacy or safety data are available from this registry record.
No effect sizes, safety signals, or efficacy comparisons available at this time.
This trial may inform whether mechanical circulatory support provides benefit in diuretic-resistant acute heart failure. Clinicians should await final results before considering this intervention outside investigational settings.
This is an active interventional trial registration with no posted results; the study is still recruiting and outcome data are not yet reported.
As stated by the source record.
Quoted from the source exactly as published.
This trial may inform whether mechanical circulatory support provides benefit in diuretic-resistant acute heart failure. Clinicians should await final results before considering this intervention outside investigational settings.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05677100). This is a study registration, not published results. Lead sponsor: Procyrion. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome, ADHF, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure; With Decompensation, Heart Failure, Congestive. Interventions: DEVICE: Aortix System. Primary outcome measures: Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up. , Baseline to 30 day Follow-Up; Primary Effectiveness Endpoint: Combined composite of clinically significant reduction in net fluid loss over 7 days and freedom from mortality or heart failure re-hospitalization/therapy escalation from the baseline visit to the 30-day follow-up visit. , Baseline to 30 day Follow-Up. Brief summary: 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 have persistent congestion despite usual medical therapy. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.