The Aortix CRS Pilot Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145635
• Other study ID #: PVP017
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: March 9, 2023

Study information

• Verified date: April 2024
• Source: Procyrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 9, 2023
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Prince Charles Hospital	Brisbane	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Western Health, Footscray Hospital	Melbourne	Victoria
Australia	St. Vincent's Hospital	Sydney	New South Wales
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Chicago	Chicago	Illinois
United States	Christ Hospital	Cincinnati	Ohio
United States	University of Colorado	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Inova Health Care Services	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	Houston Methodist	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	Columbia University/New York Presbyterian	New York	New York
United States	Sentara Hospital	Norfolk	Virginia
United States	University of California, San Francisco	San Francisco	California
United States	University of South Florida	Tampa	Florida
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Procyrion	Procyrion Australia Pty Ltd

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)	30 days
Primary	Serious Procedure Related Adverse Events	Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)	30 days
Primary	Device Performance	Deployment and retrieval procedures success rates (rates will be calculated and reported).	7 days
Primary	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
Primary	Effectiveness	Clinically significant decongestion as measured by the PA catheter. % of patients with a decrease in either CVP or PCWP of > 20%.	7 days
Primary	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
Primary	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