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The Aortix CRS Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04145635
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : January 8, 2021
Sponsor:
Collaborator:
Procyrion Australia Pty Ltd
Information provided by (Responsible Party):
Procyrion

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

Condition or disease Intervention/treatment Phase
Heart Failure; With Decompensation Cardiorenal Syndrome Cardio-Renal Syndrome Heart Failure Heart Failure,Congestive Heart Failure, Systolic Heart Failure, Diastolic Device: Aortix System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome
Estimated Study Start Date : December 31, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

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.




Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 30 days ]
    Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)

  2. Serious Procedure Related Adverse Events [ Time Frame: 30 days ]
    Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)

  3. Device Performance [ Time Frame: 7 days ]
    Deployment and retrieval procedures success rates (rates will be calculated and reported)

  4. Device Performance [ Time Frame: 30 days ]
    Rate of occurrence of ADS, ARS and pump device-related adverse events (includes device malfunctions) (rate will be calculated and reported)

  5. Effectiveness [ Time Frame: 7 days ]
    Clinically significant decongestion as measured by the PA catheter. Decrease in CVP or PCWP of > 20%.

  6. Urine Output [ Time Frame: 7 days ]
    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. BNP (Brain natriuretic peptide) [ Time Frame: 7 days ]
    Decrease in BNP or NT-pro-BNP by 20% (pre-implant vs when congestion target is met or therapy deemed ineffective)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or HFpEF);

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 [≥10 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 7 days. 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 0.125 µg/kg/min = 1 unit);

    2) Treatment with vasopressors within the past 7 days;

    3) Active and ongoing hypotension defined as a systolic blood pressure < 80 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);

    5) Exposure to intravenous contrast, aminoglycosides or high dose NSAIDS in the 7 days 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 last 7 days;;

    9) Known cirrhosis;

    10) Presence of an active infection and/or current treatment with intravenous antibiotics;

    11) Prior heart transplant, listed or planned listing for heart transplantation;

    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, cardiac sarcoidosis or Chagas disease;

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

    16) Ischemic stroke within 30 days;

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

a) Previous intracranial bleed at any time, 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 femo-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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145635


Contacts
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Contact: Beth Neely 832-536-1601 beth@procyrion.com
Contact: Tara Burt Tara@procyrion.com

Locations
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Australia, New South Wales
St. Vincent's Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Emma Norris         
Australia, Queensland
Prince Charles Hospital Recruiting
Brisbane, Queensland, Australia
Contact: Kathryn Stibijl         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Daniella Wasinski         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia
Contact: Elisha Gartner         
Sponsors and Collaborators
Procyrion
Procyrion Australia Pty Ltd
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Responsible Party: Procyrion
ClinicalTrials.gov Identifier: NCT04145635    
Other Study ID Numbers: PVP017
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Procyrion:
mechanical circulatory support, percutaneous
Additional relevant MeSH terms:
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Cardio-Renal Syndrome
Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases