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The Aortix CRS Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04145635
Recruitment Status : Completed
First Posted : October 30, 2019
Results First Posted : April 17, 2024
Last Update Posted : April 17, 2024
Sponsor:
Collaborator:
Procyrion Australia Pty Ltd
Information provided by (Responsible Party):
Procyrion

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Failure; With Decompensation
Cardiorenal Syndrome
Cardio-Renal Syndrome
Heart Failure
Heart Failure，Congestive
Heart Failure, Systolic
Heart Failure, Diastolic
Intervention Device: Aortix System
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aortix Device
Hide Arm/Group Description

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

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.
Period Title: Overall Study
Started 21
Completed 18
Not Completed 3
Arm/Group Title Aortix Device
Hide Arm/Group Description

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

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.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  50.0%
>=65 years
9
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
60.3  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 18 participants
White 15
Black/African 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 18 participants
United States 17
Australia 1
Baseline Ejection Fraction (%)  
Median (Inter-Quartile Range)
Unit of measure:  %
Number Analyzed 18 participants
22.5
(10 to 53.5)
1.Primary Outcome
Title Serious Adverse Events
Hide Description Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aortix Device
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Events
18
2.Primary Outcome
Title Serious Procedure Related Adverse Events
Hide Description Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aortix Device
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Events
7
3.Primary Outcome
Title Device Performance
Hide Description Deployment and retrieval procedures success rates (rates will be calculated and reported).
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aortix Device
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of subjects
Implant Success Rate 100
Retrieval Success Rate 100
4.Primary Outcome
Title Device Performance
Hide Description Rate of occurrence of ADS, ARS and pump device-related adverse events (includes device malfunctions) (rate will be calculated and reported)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aortix Device
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: event
1
5.Primary Outcome
Title Effectiveness
Hide Description Clinically significant decongestion as measured by the PA catheter. % of patients with a decrease in either CVP or PCWP of > 20%.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aortix Device
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: % of patients with specified decrease
89
6.Primary Outcome
Title Urine Output
Hide Description 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)
Time Frame 7 day period starting from implant
Hide Outcome Measure Data
Hide Analysis Population Description
Patients Receiving Aortix Device
Arm/Group Title Aortix Device
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 18
Median (Full Range)
Unit of Measure: mL/hr of Urine Output
Baseline Hourly Urine Output
113.7
(76.0 to 167.1)
Peak Urine Output During Treatment
236
(177.4 to 293.8)
7.Primary Outcome
Title NT-pro-BNP (Brain Natriuretic Peptide)
Hide Description Change in NT-pro-BNP (pre-implant vs when congestion target is met or therapy deemed ineffective)
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aortix Device
Hide Arm/Group Description:

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

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.
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-1,763
(-3,613 to 180)
Time Frame 2 years; timeframe is from enrollment to 30-day visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aortix Device
Hide Arm/Group Description

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

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.
All-Cause Mortality
Aortix Device
Affected / at Risk (%)
Total   2/21 (9.52%)    
Hide Serious Adverse Events
Aortix Device
Affected / at Risk (%) # Events
Total   11/21 (52.38%)    
Cardiac disorders   
Arrest, Cardiac *  1/21 (4.76%)  1
Hypotension *  1/21 (4.76%)  1
Worsening Heart Failure *  1/21 (4.76%)  1
Infections and infestations   
Urinary Tract Infection *  1/21 (4.76%)  1
Product Issues   
Device Migration/Dislodgement *  1/21 (4.76%)  1
Renal and urinary disorders   
Hepatic Dysfunction *  1/21 (4.76%)  1
Renal Injury, AKIN Stage 2 *  1/21 (4.76%)  1
Vascular disorders   
Bleeding/Femoral Access *  4/21 (19.05%)  4
Pulmonary Embolism *  1/21 (4.76%)  1
Thrombotic Vascular Complication *  2/21 (9.52%)  2
Bleeding, GI Bleed *  1/21 (4.76%)  1
Vascular Injury (NonAorta) *  2/21 (9.52%)  2
Hemolysis *  1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aortix Device
Affected / at Risk (%) # Events
Total   11/21 (52.38%)    
Blood and lymphatic system disorders   
Hemolysis *  7/21 (33.33%)  7
Gastrointestinal disorders   
GI Miscellaneous *  2/21 (9.52%)  2
Vascular disorders   
Bleeding Event *  2/21 (9.52%)  2
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rubi Reyes-Fuentez, Clinical Research Associate II
Organization: Procyrion, Inc.
EMail: rubi@procyrion.com
Layout table for additonal information
Responsible Party: Procyrion
ClinicalTrials.gov Identifier: NCT04145635    
Other Study ID Numbers: PVP017
First Submitted: October 25, 2019
First Posted: October 30, 2019
Results First Submitted: October 20, 2023
Results First Posted: April 17, 2024
Last Update Posted: April 17, 2024