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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04145635




Registration number
NCT04145635
Ethics application status
Date submitted
25/10/2019
Date registered
30/10/2019

Titles & IDs
Public title
The Aortix CRS Pilot Study
Scientific title
An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome
Secondary ID [1] 0 0
PVP017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure; With Decompensation 0 0
Cardiorenal Syndrome 0 0
Cardio-Renal Syndrome 0 0
Heart Failure 0 0
Heart Failure,Congestive 0 0
Heart Failure, Systolic 0 0
Heart Failure, Diastolic 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Aortix System

Experimental: Aortix Device - Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serious Adverse Events
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Serious Procedure Related Adverse Events
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Device Performance
Timepoint [3] 0 0
7 days
Primary outcome [4] 0 0
Device Performance
Timepoint [4] 0 0
30 days
Primary outcome [5] 0 0
Effectiveness
Timepoint [5] 0 0
7 days
Primary outcome [6] 0 0
Urine Output
Timepoint [6] 0 0
7 day period starting from implant
Primary outcome [7] 0 0
NT-pro-BNP (Brain Natriuretic Peptide)
Timepoint [7] 0 0
7 days

Eligibility
Key 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.

-
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/03/2023
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Western Health, Footscray Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Procyrion
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Procyrion Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04145635