Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Conditions

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

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aortix System — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Aug 23, 2023

Status verified

Jun 2026

Primary completion

Jan 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Arm
  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.
• No Intervention: Control Arm
  The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
• Experimental: Advanced HF Registry
  For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.

Primary Outcome Measure

Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up. [ Time Frame: Baseline to 30 day Follow-Up ]

Central Contacts

• Rubi Reyes-Fuentez
  832-536-1601
  [email protected]

Locations (47)

Find similar trials in Phoenix, AZ

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