Heart Failure; With DecompensationNCT04145635
The Aortix CRS Pilot Study
A study testing Aortix System in people with Heart Failure; With Decompensation and Cardiorenal Syndrome, run by Procyrion at 19 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome
- What is being tested?
- Aortix System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 5 Feb 2021to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- dyspnea at rest or with minimal exertion,
- paroxysmal nocturnal dyspnea,
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- orthopnea,
- lower extremity edema (≥2+),
- elevated jugular venous pressure,
- pulmonary rales,
- enlarged liver or ascites,
- pulmonary vascular congestion on chest x-ray;
- 5) Age >21 years.
- -
Who cannot join
- 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;
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- 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):
- 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:
- 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)],
- Abnormalities of the aorta or iliac arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications,
- 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,
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Chicago
Chicago, Illinois, 60637
Christ Hospital
Cincinnati, Ohio, 45219
University of Colorado
Denver, Colorado, 80045
Henry Ford Health System
Detroit, Michigan, 48202
Inova Health Care Services
Falls Church, Virginia, 20042
University of Florida
Gainesville, Florida, 32610
Houston Methodist
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
Columbia University/New York Presbyterian
New York, New York, 10032
Sentara Hospital
Norfolk, Virginia, 23502
University of California, San Francisco
San Francisco, California, 94143
University of South Florida
Tampa, Florida, 33620
Cleveland Clinic Florida
Weston, Florida, 33331
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia
Prince Charles Hospital
Brisbane, Queensland
The Alfred Hospital
Melbourne, Victoria
Western Health, Footscray Hospital
Melbourne, Victoria
St. Vincent's Hospital
Sydney, New South Wales
About this 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
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
Read the 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.
- Conditions
- Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure, Heart Failure，Congestive, Heart Failure, Systolic
- Being tested
- Aortix System
- Keywords
- mechanical circulatory support, percutaneous
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome, Heart Failure, Systolic, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortix SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aortix Device | Experimental | Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System Receives: Device: Aortix System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)
Measured: 30 days
Serious Procedure Related Adverse Events
Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)
Measured: 30 days
Device Performance
Deployment and retrieval procedures success rates (rates will be calculated and reported).
Measured: 7 days
Device Performance
Rate of occurrence of ADS, ARS and pump device-related adverse events (includes device malfunctions) (rate will be calculated and reported)
Measured: 30 days
Effectiveness
Clinically significant decongestion as measured by the PA catheter. % of patients with a decrease in either CVP or PCWP of > 20%.
Measured: 7 days
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)
Measured: 7 day period starting from implant
NT-pro-BNP (Brain Natriuretic Peptide)
Change in NT-pro-BNP (pre-implant vs when congestion target is met or therapy deemed ineffective)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start5 Feb 2021
- Primary completion7 Oct 2022
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procyrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procyrion Australia Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145635
- Sponsor's protocol ID
- PVP017
- Status last verified
- Apr 2024
- First submitted
- 25 Oct 2019
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cowger JA, Basir MB, Baran DA, Hayward CS, Rangaswami J, Walton A, Tita C, Minear S, Hakemi E, Klein L, Cheng R, Wu R, Mohanty BD, Heuring JJ, Neely E, Shah P; Aortix CRS Pilot Study Investigators. Safety and Performance of the Aortix Device in Acute Decompensated Heart Failure and Cardiorenal Syndrome. JACC Heart Fail. 2023 Nov;11(11):1565-1575. doi: 10.1016/j.jchf.2023.06.018. Epub 2023 Oct 4.
PubMed 37804307
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome
- ClinicalTrials.gov ID
- NCT04145635
- Acronym / sponsor ID
- PVP017
- Conditions
- Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure, Heart Failure，Congestive, Heart Failure, Systolic
- Keywords
- mechanical circulatory support, percutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ProcyrionIndustry (pharma, biotech, devices)
- Collaborators
- Procyrion Australia Pty Ltd
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortix Device | Experimental | Device: Aortix SystemAortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- dyspnea at rest or with minimal exertion,
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortix SystemAortix 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. | Device | Aortix Device |
Primary outcome
Serious Adverse Events
Time frame: 30 days
Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)
Serious Procedure Related Adverse Events
Time frame: 30 days
Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)
Device Performance
Time frame: 7 days
Deployment and retrieval procedures success rates (rates will be calculated and reported).
Device Performance
Time frame: 30 days
Rate of occurrence of ADS, ARS and pump device-related adverse events (includes device malfunctions) (rate will be calculated and reported)
Effectiveness
Time frame: 7 days
Clinically significant decongestion as measured by the PA catheter. % of patients with a decrease in either CVP or PCWP of > 20%.
Urine Output
Time frame: 7 day period starting from implant
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)
NT-pro-BNP (Brain Natriuretic Peptide)
Time frame: 7 days
Change in NT-pro-BNP (pre-implant vs when congestion target is met or therapy deemed ineffective)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37804307Cowger JA, Basir MB, Baran DA, Hayward CS, Rangaswami J, Walton A, Tita C, Minear S, Hakemi E, Klein L, Cheng R, Wu R, Mohanty BD, Heuring JJ, Neely E, Shah P; Aortix CRS Pilot Study Investigators. Safety and Performance of the Aortix Device in Acute Decompensated Heart Failure and Cardiorenal Syndrome. JACC Heart Fail. 2023 Nov;11(11):1565-1575. doi: 10.1016/j.jchf.2023.06.018. Epub 2023 Oct 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortix System in people with Heart Failure; With Decompensation and Cardiorenal Syndrome, run by Procyrion at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.