NCT05677100

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Procyrion · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 patients 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. This study will enroll up to 320 subjects with heart failure at 50 clinical sites in the United States and up to 5 OUS sites. The randomized study includes up to 240 subjects and the Advanced HF registry includes up to 80 subjects.

Conditions

• Heart Failure
• Cardiorenal Syndrome
• Cardio-Renal Syndrome
• ADHF
• Heart Failure, Systolic
• Heart Failure, Diastolic
• Heart Failure; With Decompensation
• Heart Failure, Congestive

Interventions

Type	Name	Description
DEVICE	Aortix System	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.

Timeline

• Start date: 2023-08-23
• Primary completion: 2027-01-01
• Completion: 2027-08-01
• First posted: 2023-01-10
• Last updated: 2026-04-07

Locations

48 sites across 2 countries: United States, Hungary

Regulatory

• FDA-regulated device study