The Aortix CRS Pilot Study

NCT ID: NCT04145635

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2023-03-09

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aortix Device

Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System

Group Type: EXPERIMENTAL

Aortix System

Intervention Type: 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) with worsening renal function.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procyrion Australia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Procyrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Southern California

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

University of South Florida

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

University of Chicago

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Columbia University/New York Presbyterian

New York, New York, United States

Christ Hospital

Cincinnati, Ohio, United States

Houston Methodist

Houston, Texas, United States

Inova Health Care Services

Falls Church, Virginia, United States

Sentara Hospital

Norfolk, Virginia, United States

St. Vincent's Hospital

Sydney, New South Wales, Australia

Prince Charles Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Western Health, Footscray Hospital

Melbourne, Victoria, Australia

Countries

United States; Australia

References

Cowger JA, Basir MB, Baran DA, Hayward CS, Rangaswami J, Walton A, Tita C, Minear S, Hakemi E, Klein L, Cheng R, Wu R, Mohanty BD, Heuring JJ, Neely E, Shah P; Aortix CRS Pilot Study Investigators. Safety and Performance of the Aortix Device in Acute Decompensated Heart Failure and Cardiorenal Syndrome. JACC Heart Fail. 2023 Nov;11(11):1565-1575. doi: 10.1016/j.jchf.2023.06.018. Epub 2023 Oct 4.

Reference Type: DERIVED

PMID: 37804307 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PVP017

Identifier Type: -

Identifier Source: org_study_id