The Aortix CRS Pilot Study

• ClinicalTrials.gov Identifier: NCT04145635
• Recruitment Status: Recruiting
• First Posted: October 30, 2019
• Last Update Posted: January 8, 2021
• Sponsor: Procyrion
• Collaborator: Procyrion Australia Pty Ltd
• Information provided by (Responsible Party): Procyrion

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Beth Neely; 832-536-1601; beth@procyrion.com

Contact: Tara Burt; Tara@procyrion.com

Locations

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

More Information

• Responsible Party: Procyrion
• ClinicalTrials.gov Identifier: NCT04145635
• Other Study ID Numbers: PVP017
• First Posted: October 30, 2019
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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