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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04145635
Other study ID # PVP017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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. - 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.

Study Design


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
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