The Aortix CRS Pilot Study

• Sponsor: Procyrion (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04145635
• Collaborator: Procyrion Australia Pty Ltd (Other)
• Enrollment: 60
• Locations: 20
• Arm: 1
• Anticipated Duration (Months): 24.8
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

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	N/A

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
• Anticipated Enrollment: 60 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
• Actual Study Start Date: Feb 5, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

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 [30 days]

   Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)

2. Serious Procedure Related Adverse Events [30 days]

   Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)

3. Device Performance [7 days]

   Deployment and retrieval procedures success rates (rates will be calculated and reported)

4. Device Performance [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 [7 days]

   Clinically significant decongestion as measured by the PA catheter. Decrease in CVP or PCWP of > 20%.

6. Urine Output [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) [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

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

1. 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):

1. 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);

1. Current endovascular stent graft in the descending aorta or any femoro-iliac vessels;

2. 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)],

1. Abnormalities of the aorta or iliac arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications,

2. 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,

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

1. 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);

1. Positive pregnancy test if of childbearing potential;

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	University of California, San Francisco	San Francisco	California	United States	94143
3	University of Colorado	Denver	Colorado	United States	80045
4	University of Florida	Gainesville	Florida	United States	32610
5	University of South Florida	Tampa	Florida	United States	33620
6	Cleveland Clinic Florida	Weston	Florida	United States	33331
7	University of Chicago	Chicago	Illinois	United States	60637
8	University of Michigan	Ann Arbor	Michigan	United States	48109
9	Henry Ford Health System	Detroit	Michigan	United States	48202
10	Columbia University/New York Presbyterian	New York	New York	United States	10032
11	Christ Hospital	Cincinnati	Ohio	United States	45219
12	Houston Methodist	Houston	Texas	United States	77030
13	Inova Health Care Services	Falls Church	Virginia	United States	20042
14	Sentara Hospital	Norfolk	Virginia	United States	23502
15	St. Vincent's Hospital	Sydney	New South Wales	Australia
16	Prince Charles Hospital	Brisbane	Queensland	Australia
17	St Andrew's War Memorial Hospital	Brisbane	Queensland	Australia
18	Royal Adelaide Hospital	Adelaide	South Australia	Australia
19	The Alfred Hospital	Melbourne	Victoria	Australia
20	Western Health, Footscray Hospital	Melbourne	Victoria	Australia

Sponsors and Collaborators

• Procyrion
• Procyrion Australia Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Procyrion
• ClinicalTrials.gov Identifier: NCT04145635
• Other Study ID Numbers: PVP017
• First Posted: Oct 30, 2019
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Procyrion: mechanical circulatory support, percutaneous
• Additional relevant MeSH terms: Cardio-Renal Syndrome; Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic; Syndrome

Study Results

No Results Posted as of May 25, 2022