Trial Outcomes & Findings for CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass (NCT NCT00819793)
NCT ID: NCT00819793
Last Updated: 2022-06-27
Results Overview
Number of patients alive 30 days after device implantation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant
Results posted on
2022-06-27
Participant Flow
Protocol included an enrollment allowance of 30 subjects at 25 centers for subjects who fail to wean from cardiopulmonary bypass. 2 additional patients were enrolled to increase the number of LVAD use in the study. Subject enrollment commenced in October 2008. A total of 18 sites participated in the study.
Participant milestones
| Measure |
Patients Supported by the CentriMag Ventricular Assist System
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some lab values not submitted for all patients
Baseline characteristics by cohort
| Measure |
CentriMag Ventricular Assist System
n=32 Participants
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
CentriMag Ventricular Assist System: All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
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|---|---|
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Age, Continuous
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58 years
STANDARD_DEVIATION 13.8 • n=32 Participants
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Sex: Female, Male
Female
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8 Participants
n=32 Participants
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Sex: Female, Male
Male
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24 Participants
n=32 Participants
|
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Medical History
Smoking
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14 Participants
n=32 Participants
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Medical History
Diabetes
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12 Participants
n=32 Participants
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Medical History
Hyperlipidemia
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16 Participants
n=32 Participants
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Medical History
Prior Cardiovascular Events
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29 Participants
n=32 Participants
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Ethnicity/Race
African American
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4 Participants
n=32 Participants
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Ethnicity/Race
Asian
|
0 Participants
n=32 Participants
|
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Ethnicity/Race
Hispanic
|
2 Participants
n=32 Participants
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Ethnicity/Race
Native American
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0 Participants
n=32 Participants
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Ethnicity/Race
White
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24 Participants
n=32 Participants
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Ethnicity/Race
Other
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2 Participants
n=32 Participants
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Heart Rate
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91.1 beats per minute
STANDARD_DEVIATION 21.4 • n=32 Participants
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Laboratory Values
Blood Urea Nitrogen
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39.1 mg/dl
STANDARD_DEVIATION 21.3 • n=32 Participants • Some lab values not submitted for all patients
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Laboratory Values
Creatinine
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1.8 mg/dl
STANDARD_DEVIATION 0.8 • n=32 Participants • Some lab values not submitted for all patients
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Laboratory Values
Total Bilirubin
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1.8 mg/dl
STANDARD_DEVIATION 1.8 • n=31 Participants • Some lab values not submitted for all patients
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Laboratory Values
Plasma Free Hemoglobin
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28.8 mg/dl
STANDARD_DEVIATION 28.9 • n=20 Participants • Some lab values not submitted for all patients
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Hemodynamic Values
Systolic Blood Pressure
|
98.6 mmHg
STANDARD_DEVIATION 23.2 • n=30 Participants • Hemodynamics were unable to be collected on all patients
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Hemodynamic Values
Diastolic Blood Pressure
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54.2 mmHg
STANDARD_DEVIATION 12.7 • n=30 Participants • Hemodynamics were unable to be collected on all patients
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Hemodynamic Values
Pulmonary Artery Systolic
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37.3 mmHg
STANDARD_DEVIATION 14.0 • n=22 Participants • Hemodynamics were unable to be collected on all patients
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Hemodynamic Values
Pulmonary Artery Diastolic
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22.9 mmHg
STANDARD_DEVIATION 8.5 • n=22 Participants • Hemodynamics were unable to be collected on all patients
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Hemodynamic Values
Central Venous Pressure
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16.3 mmHg
STANDARD_DEVIATION 8.0 • n=26 Participants • Hemodynamics were unable to be collected on all patients
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Glasgow Coma Scale
Eye Opening : Not done
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2 Participants
n=32 Participants
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Glasgow Coma Scale
Eye Opening : No response
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17 Participants
n=32 Participants
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Glasgow Coma Scale
Eye Opening : Response to speech
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3 Participants
n=32 Participants
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Glasgow Coma Scale
Eye Opening : Spontaneous eye opening
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10 Participants
n=32 Participants
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Glasgow Coma Scale
Motor response: Not done
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2 Participants
n=32 Participants
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Glasgow Coma Scale
Motor response: No response to pain
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13 Participants
n=32 Participants
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Glasgow Coma Scale
Motor response: Withdrawal to pain stimuli
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2 Participants
n=32 Participants
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Glasgow Coma Scale
Motor response: Localizes pain
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1 Participants
n=32 Participants
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Glasgow Coma Scale
Motor response: Obeys commands
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14 Participants
n=32 Participants
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Glasgow Coma Scale
Verbal response: Not done
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2 Participants
n=32 Participants
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Glasgow Coma Scale
Verbal response: No verbalization
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19 Participants
n=32 Participants
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Glasgow Coma Scale
Verbal response: Normal conversation
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11 Participants
n=32 Participants
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Body Surface Area
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2.05 Meters squared
STANDARD_DEVIATION 0.25 • n=32 Participants
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Cardiac Index
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1.6 L/min/m^2
STANDARD_DEVIATION 0.4 • n=10 Participants • Hemodynamics were unable to be collected on all patients
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Cardiac Output
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3.9 L/min
STANDARD_DEVIATION 1.3 • n=11 Participants • Hemodynamics were unable to be collected on all patients
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Respiratory Rate
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17.6 Breaths per minute
STANDARD_DEVIATION 6.5 • n=30 Participants • Respiratory rate data not submitted for two patients
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PRIMARY outcome
Timeframe: 30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplantNumber of patients alive 30 days after device implantation
Outcome measures
| Measure |
Patients Supported by the CentriMag Ventricular Assist System
n=32 Participants
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
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|---|---|
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Survival
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20 Participants
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SECONDARY outcome
Timeframe: Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAPPopulation: measurements not made in all subjects
Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP.
Outcome measures
| Measure |
Patients Supported by the CentriMag Ventricular Assist System
n=32 Participants
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
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|---|---|
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Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
CVP
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-5.5 mmHg
Standard Deviation 4.1
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Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
Mean arterial pressure
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7.7 mmHg
Standard Deviation 11.9
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Adverse Events
Patients Supported by the CentriMag Ventricular Assist System
Serious events: 32 serious events
Other events: 0 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Patients Supported by the CentriMag Ventricular Assist System
n=32 participants at risk
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
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|---|---|
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Blood and lymphatic system disorders
Major bleeding
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81.2%
26/32 • Number of events 73 • From CentriMag implant, during support, and for 6 months post device-removal
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Cardiac disorders
Cardiac arrhythmias
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34.4%
11/32 • Number of events 13 • From CentriMag implant, during support, and for 6 months post device-removal
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Cardiac disorders
Pericardial fluid collection
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0.00%
0/32 • From CentriMag implant, during support, and for 6 months post device-removal
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Blood and lymphatic system disorders
Hemolysis
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12.5%
4/32 • Number of events 4 • From CentriMag implant, during support, and for 6 months post device-removal
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Hepatobiliary disorders
Hepatic dysfunction
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3.1%
1/32 • Number of events 1 • From CentriMag implant, during support, and for 6 months post device-removal
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Cardiac disorders
Hypertension
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3.1%
1/32 • Number of events 1 • From CentriMag implant, during support, and for 6 months post device-removal
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Infections and infestations
Major infection
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40.6%
13/32 • Number of events 22 • From CentriMag implant, during support, and for 6 months post device-removal
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Cardiac disorders
Myocardial infarction
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0.00%
0/32 • From CentriMag implant, during support, and for 6 months post device-removal
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Nervous system disorders
Neurologic dysfunction
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0.00%
0/32 • From CentriMag implant, during support, and for 6 months post device-removal
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Psychiatric disorders
Psychiatric episode
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6.2%
2/32 • Number of events 2 • From CentriMag implant, during support, and for 6 months post device-removal
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Renal and urinary disorders
Renal dysfunction
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21.9%
7/32 • Number of events 7 • From CentriMag implant, during support, and for 6 months post device-removal
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Respiratory, thoracic and mediastinal disorders
Respiratory failure
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43.8%
14/32 • Number of events 14 • From CentriMag implant, during support, and for 6 months post device-removal
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Cardiac disorders
Right heart failure
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6.2%
2/32 • Number of events 2 • From CentriMag implant, during support, and for 6 months post device-removal
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Vascular disorders
Arterial non-CNS thromboembolism
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3.1%
1/32 • Number of events 1 • From CentriMag implant, during support, and for 6 months post device-removal
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Blood and lymphatic system disorders
Venous thromboembolism
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3.1%
1/32 • Number of events 1 • From CentriMag implant, during support, and for 6 months post device-removal
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Skin and subcutaneous tissue disorders
Wound dehiscence
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3.1%
1/32 • Number of events 1 • From CentriMag implant, during support, and for 6 months post device-removal
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General disorders
Other adverse event
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18.8%
6/32 • Number of events 7 • From CentriMag implant, during support, and for 6 months post device-removal
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Other adverse events
| Measure |
Patients Supported by the CentriMag Ventricular Assist System
n=32 participants at risk
All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.
Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.
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|---|---|
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General disorders
Other adverse events
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0.00%
0/32 • From CentriMag implant, during support, and for 6 months post device-removal
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place