Trial Outcomes & Findings for The Aortix CRS Pilot Study (NCT NCT04145635)

NCT ID: NCT04145635

Last Updated: 2024-04-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-04-17

Participant Flow

Participant milestones

Measure	Aortix Device 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 Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Aortix CRS Pilot Study

Baseline characteristics by cohort

Measure	Aortix Device n=18 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized White	15 participants n=5 Participants
Race/Ethnicity, Customized Black/African	3 participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Region of Enrollment Australia	1 participants n=5 Participants
Baseline Ejection Fraction (%)	22.5 % n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	Aortix Device n=18 Participants 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.
Serious Adverse Events	18 Events

PRIMARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	Aortix Device n=18 Participants 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.
Serious Procedure Related Adverse Events	7 Events

PRIMARY outcome

Timeframe: 7 days

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

Outcome measures

Measure	Aortix Device n=18 Participants 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.
Device Performance Implant Success Rate	100 percentage of subjects
Device Performance Retrieval Success Rate	100 percentage of subjects

PRIMARY outcome

Timeframe: 30 days

Rate of occurrence of ADS, ARS and pump device-related adverse events (includes device malfunctions) (rate will be calculated and reported)

Outcome measures

Measure	Aortix Device n=18 Participants 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.
Device Performance	1 event

PRIMARY outcome

Timeframe: 7 days

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

Outcome measures

Measure	Aortix Device n=18 Participants 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.
Effectiveness	89 % of patients with specified decrease

PRIMARY outcome

Timeframe: 7 day period starting from implant

Population: Patients Receiving Aortix Device

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)

Outcome measures

Measure	Aortix Device n=18 Participants 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.
Urine Output Baseline Hourly Urine Output	113.7 mL/hr of Urine Output Interval 76.0 to 167.1
Urine Output Peak Urine Output During Treatment	236 mL/hr of Urine Output Interval 177.4 to 293.8

PRIMARY outcome

Timeframe: 7 days

Change in NT-pro-BNP (pre-implant vs when congestion target is met or therapy deemed ineffective)

Outcome measures

Measure	Aortix Device n=17 Participants 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.
NT-pro-BNP (Brain Natriuretic Peptide)	-1,763 pg/mL Interval to 180.0

Adverse Events

Aortix Device

Serious events: 11 serious events

Other events: 11 other events

Deaths: 2 deaths

Serious adverse events

Measure	Aortix Device n=21 participants at risk 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.
Cardiac disorders Arrest, Cardiac	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Vascular disorders Bleeding/Femoral Access	19.0% 4/21 • Number of events 4 • 2 years; timeframe is from enrollment to 30-day visit.
Vascular disorders Pulmonary Embolism	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Infections and infestations Urinary Tract Infection	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Vascular disorders Thrombotic Vascular Complication	9.5% 2/21 • Number of events 2 • 2 years; timeframe is from enrollment to 30-day visit.
Vascular disorders Bleeding, GI Bleed	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Vascular disorders Vascular Injury (NonAorta)	9.5% 2/21 • Number of events 2 • 2 years; timeframe is from enrollment to 30-day visit.
Product Issues Device Migration/Dislodgement	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Vascular disorders Hemolysis	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Renal and urinary disorders Hepatic Dysfunction	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Cardiac disorders Hypotension	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Renal and urinary disorders Renal Injury, AKIN Stage 2	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.
Cardiac disorders Worsening Heart Failure	4.8% 1/21 • Number of events 1 • 2 years; timeframe is from enrollment to 30-day visit.

Other adverse events

Measure	Aortix Device n=21 participants at risk 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.
Vascular disorders Bleeding Event	9.5% 2/21 • Number of events 2 • 2 years; timeframe is from enrollment to 30-day visit.
Gastrointestinal disorders GI Miscellaneous	9.5% 2/21 • Number of events 2 • 2 years; timeframe is from enrollment to 30-day visit.
Blood and lymphatic system disorders Hemolysis	33.3% 7/21 • Number of events 7 • 2 years; timeframe is from enrollment to 30-day visit.

Additional Information

Rubi Reyes-Fuentez, Clinical Research Associate II

Procyrion, Inc.

Phone: -

Email: rubi@procyrion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place