Clinical trial NCT04145635: The Aortix CRS Pilot Study
Official title: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure; With Decompensation
Cardiorenal Syndrome
Cardio-Renal Syndrome
Heart Failure
Heart Failure，Congestive
Heart Failure, Systolic
Heart Failure, Diastolic
Keywords: mechanical circulatory support, percutaneous
Lead sponsor: Procyrion
Sponsor class: INDUSTRY
Collaborators: name: Procyrion Australia Pty Ltd
First posted: 2019-10-30
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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, 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.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 30 days
measure: Serious Procedure Related Adverse Events
timeFrame: 30 days
measure: Device Performance
timeFrame: 7 days
measure: Device Performance
timeFrame: 30 days
measure: Effectiveness
timeFrame: 7 days
measure: Urine Output
timeFrame: 7 day period starting from implant
measure: NT-pro-BNP (Brain Natriuretic Peptide)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: Columbia University/New York Presbyterian
state: New York
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
city: Norfolk
country: United States
facility: Sentara Hospital
state: Virginia
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Western Health, Footscray Hospital
state: Victoria
Study officials:
References: