The Aortix CRS Pilot Study

NCT04145635 | Completed Results DMC FDA Device

• 1 other identifier: PVP017
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 19

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

Conditions

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

Keywords

mechanical circulatory support, percutaneous

Outcome Measures

Primary Outcomes (7)

• Serious Adverse Events

  Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)

  30 days

• Serious Procedure Related Adverse Events

  Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)

  30 days

• Device Performance

  Deployment and retrieval procedures success rates (rates will be calculated and reported).

  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)

  30 days

• Effectiveness

  Clinically significant decongestion as measured by the PA catheter. % of patients with a decrease in either CVP or PCWP of \> 20%.

  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)

  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)

  7 days

Study Arms (1)

Aortix Device

EXPERIMENTAL

Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System

Device: Aortix System

Interventions

Aortix System DEVICE

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.

Aortix Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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);
• \) 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;
• \) Objective measure of congestion (Elevated PCWP \[≥20 mmHg\] OR Elevated CVP \[≥12 mmHg\]) obtained via catheter measurement;
• \) 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,
• orthopnea,
• lower extremity edema (≥2+),
• elevated jugular venous pressure,
• pulmonary rales,
• enlarged liver or ascites,
• pulmonary vascular congestion on chest x-ray;
• \) Age \>21 years.

You may not qualify if:

• \) 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);
• \) 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;
• \) Acute Kidney Failure defined as increase in serum creatinine to ≥4.0 mg/dL (≥353.6 μmol/L) within the last 48 hours;
• \) Exposure to intravenous contrast, aminoglycosides or high dose NSAIDS in the 48 hours before enrollment;
• \) Known or suspected contrast induced nephropathy;
• \) 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;
• \) Urologic intervention (except indwelling urinary (Foley) catheter)) within the last 7 days;
• \) Known cirrhosis or shock liver;
• \) Presence of an active infection;
• \) 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;
• \) 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;
• \) Patient has known hypo- or hyper coaguable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT);
• \) Known cardiac amyloidosis;
• \) Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization;
• \) Stroke within 30 days of enrollment;

Sponsors & Collaborators

• Procyrion: lead
• Procyrion Australia Pty Ltd: collaborator

Study Sites (19)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Columbia University/New York Presbyterian

New York, New York, 10032, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Inova Health Care Services

Falls Church, Virginia, 20042, United States

Location

Sentara Hospital

Norfolk, Virginia, 23502, United States

Location

St. Vincent's Hospital

Sydney, New South Wales, Australia

Location

Prince Charles Hospital

Brisbane, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

Western Health, Footscray Hospital

Melbourne, Victoria, Australia

Location

Related Publications (1)

• 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.

  PMID: 37804307 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardio-Renal Syndrome; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Larger samples and a study powered to allow comparison with SOC is needed to confirm decongestion and renal benefits from IAEP and to identify a HF pt group that would benefit the most. An 18F sheath is required for device deployment, pts require systemic anticoagulation, and ICU monitoring was required. The implant procedure should be validated with various operators; the efficacy, performance, and safety of IAEP should be studied in a RCT; and consider extra costs of therapy vs pt outcomes.

Results Point of Contact

• Title: Rubi Reyes-Fuentez, Clinical Research Associate II
• Organization: Procyrion, Inc.

rubi@procyrion.com

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Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 30, 2019
• Study Start: February 5, 2021
• Primary Completion: October 7, 2022
• Study Completion: March 9, 2023
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); AU (5)