The Aortix CRS Pilot Study

An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome

The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome

Study Overview

• Status: Completed
• Conditions: Heart Failure; Heart Failure, Diastolic; Cardio-Renal Syndrome; Heart Failure, Systolic; Heart Failure; With Decompensation; Heart Failure，Congestive; Cardiorenal Syndrome
• Intervention / Treatment: Device: Aortix System

Detailed Description

The study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and performance of the Aortix System in patients hospitalized with acute decompensated heart failure (ADHF) and worsening renal function refractory to medical management with persistent congestion. The Aortix system consists of the Aortix Delivery System, Introducer Set, the Aortix Pump, the Aortix Control System, and the Aortix Retrieval System.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • St. Vincent's Hospital
  • Queensland
    • Brisbane, Queensland, Australia
      • Prince Charles Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Royal Adelaide Hospital
  • Victoria
    • Melbourne, Victoria, Australia
      • The Alfred Hospital
    • Melbourne, Victoria, Australia
      • Western Health, Footscray Hospital
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Tampa, Florida, United States, 33620
      • University of South Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • New York
    • New York, New York, United States, 10032
      • Columbia University/New York Presbyterian
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
  • Virginia
    • Falls Church, Virginia, United States, 20042
      • Inova Health Care Services
    • Norfolk, Virginia, United States, 23502
      • Sentara Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1) Admitted to the hospital with a primary diagnosis of acute decompensated heart failure, either heart failure with reduced or preserved ejection fraction (HFrEF, HFpEF or HFmEF);

2) Worsening renal function (serum creatinine increase by ≥0.3 mg/dl [≥27 μmol/L]) despite 48 hours of intravenous diuretic therapy Increase can be compared to a baseline value taken within 90 days of hospitalization or during hospitalization;

3) Objective measure of congestion (Elevated PCWP [≥20 mmHg] OR Elevated CVP [≥12 mmHg]) obtained via catheter measurement;

4) Persistent clinical signs and/or symptoms of congestion despite diuretic therapy (one or more of the following):

1. dyspnea at rest or with minimal exertion,
2. paroxysmal nocturnal dyspnea,
3. orthopnea,
4. lower extremity edema (≥2+),
5. elevated jugular venous pressure,
6. pulmonary rales,
7. enlarged liver or ascites,

8. pulmonary vascular congestion on chest x-ray;

   5) Age >21 years.

   -

   Exclusion Criteria:

   1) Treatment with high dose IV inotropes within the last 48 hours. High dose is defined as > 1 unit of inotrope (excluding digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit, (for example, dopamine 2.5 µg/kg/min + dobutamine 2.5 µg/kg/min = 1 unit; dobutamine 2.5 µg/kg/min + milrinone 0.1875 µg/kg/min = 1 unit);

   2) Treatment with vasopressors to maintain blood pressure as per exclusion number 3;

   3) Active and ongoing hypotension defined as a systolic blood pressure < 90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) < 60 mmHg lasting more than 30 minutes;

   4) Acute Kidney Failure defined as increase in serum creatinine to ≥4.0 mg/dL (≥353.6 μmol/L) within the last 48 hours;

   5) Exposure to intravenous contrast, aminoglycosides or high dose NSAIDS in the 48 hours before enrollment;

   6) Known or suspected contrast induced nephropathy;

   7) Prior kidney transplant, isolated single kidney, stage V Chronic Kidney Disease (eGFR ≤15) at admission OR use of dialysis, continuous renal replacement therapy (CRRT) or aquapheresis (ultrafiltration) in last 90 days;

   8) Urologic intervention (except indwelling urinary (Foley) catheter)) within the last 7 days;

   9) Known cirrhosis or shock liver;

   10) Presence of an active infection;

   11) Prior heart transplant in the last 2 years, heart failure due to rejection of a previous heart transplant, planned heart transplantation before the 30-day follow-up visit;

   12) Current or previous support with a durable LVAD at any time or use of an intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) currently or within the last 30 days;

   13) Patient has known hypo- or hyper coaguable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT);

   14) Known cardiac amyloidosis;

   15) Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization;

   16) Stroke within 30 days of enrollment;

   17) Severe Bleeding Risk (any of the following):

a) Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days, b) GI bleeding within 6 months requiring hospitalization and/or transfusion, c) Recent major surgery within 6 months if the surgical wound is judged to be associated with an increased risk of bleeding, d) Endovascular procedure with ilio-femoral access > 6 FR within 30 days, e) Platelet count <75,000 cells/mm3, f) Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy);

18) Current endovascular stent graft in the descending aorta or any femoro-iliac vessels;

19) Contraindicated Anatomy:

1. Descending aortic anatomy that would prevent safe placement of the device [<18mm or >31mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)],
2. Abnormalities of the aorta or iliac arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications,
3. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath including severe obstructive calcification or severe tortuosity,

4. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury;

   20) Known hypersensitivity or contraindication to study or procedure medications (e.g.

   anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol);

   21) Positive pregnancy test if of childbearing potential;

   22) Participation in any other clinical investigation that is likely to confound study results or affect the study;

   23) Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aortix Device; Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System	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) with worsening renal function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)	30 days
Serious Procedure Related Adverse Events	Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)	30 days
Device Performance	Rate of occurrence of ADS, ARS and pump device-related adverse events (includes device malfunctions) (rate will be calculated and reported)	30 days
Device Performance	Deployment and retrieval procedures success rates (rates will be calculated and reported).	7 days
Effectiveness	Clinically significant decongestion as measured by the PA catheter. % of patients with a decrease in either CVP or PCWP of > 20%.	7 days
Urine Output	Change in Urine Output Assessed as the hourly rate of urine output before pump placed vs hourly rate of urine output over the Aortix therapy period (until congestion target met or therapy deemed ineffective)	7 day period starting from implant
NT-pro-BNP (Brain Natriuretic Peptide)	Change in NT-pro-BNP (pre-implant vs when congestion target is met or therapy deemed ineffective)	7 days

Collaborators and Investigators

• Sponsor: Procyrion
• Collaborators: Procyrion Australia Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: mechanical circulatory support, percutaneous
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Disease; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Syndrome; Heart Failure, Diastolic; Heart Failure, Systolic; Cardio-Renal Syndrome
• Other Study ID Numbers: PVP017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes