CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00819793
• Collaborator: Thoratec Corporation (Industry)
• Enrollment: 32
• Locations: 14
• Arm: 1
• Duration (Months): 59
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CentriMag Ventricular Assist System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: CentriMag Ventricular Assist System All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.

Device: 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.

Outcome Measures

Primary Outcome Measures

1. Survival [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]

   Number of patients alive 30 days after device implantation

Secondary Outcome Measures

1. Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP) [Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years of age

• Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass

• Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.

• All subjects must meet the following criteria at the time of enrollment:

• Hemodynamics:

1. cardiac index ≤ 2.2 L/min/m2

2. For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg

3. For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat

4. Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.

• Placement of an intra-aortic balloon pump has been attempted unless contraindicated

• All possible measures have been attempted to correct low arterial pH, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, dysrhythmias and residual hypothermia

• Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted

• Written, signed, and dated informed consent

Exclusion Criteria:

• BUN > 100 mg/dl

• Creatinine > 5 mg/dl

• Presence of any investigational mechanical circulatory support device

• Known history of liver cirrhosis or portal hypertension

• Pulmonary infarction

• Stroke, TIA or history of either condition within the last six months and/or any confirmed, existing neurologic deficits

• Active systemic infection defined as positive blood cultures, core temperature >100.5 degrees, white blood count > 12,500, and treatment with antimicrobials

• Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study

• Other serious disease(s) limiting life expectancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Hospital, Arizona	Phoenix	Arizona	United States	85054
2	Yale University	New Haven	Connecticut	United States	06510
3	University of Kentucky	Lexington	Kentucky	United States	40536
4	University of Maryland	Baltimore	Maryland	United States	21201
5	Fairview University Medical Center	Minneapolis	Minnesota	United States	55455
6	New York Columbia Presbyterian Hospital	New York	New York	United States	10032
7	University of Rochester	Rochester	New York	United States	14642
8	Duke University Medical Center	Durham	North Carolina	United States	27710
9	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
10	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
11	St. Luke's Episcopal	Houston	Texas	United States	77030
12	Intermountain Medical Center	Murray	Utah	United States	84107
13	University of Utah	Salt Lake City	Utah	United States	84132
14	St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices
• Thoratec Corporation

Investigators

• Study Director: Pooja Chatterjee, Abbott Medical Devices

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00819793
• Other Study ID Numbers: LXP-002
• First Posted: Jan 9, 2009
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Abbott Medical Devices: Cardiac Dysfunction; Failure-to-wean from CPB; CentriMag; Levitronix; Thoratec Corporation
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Patients Supported by the CentriMag Ventricular Assist System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	32
COMPLETED	32
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	CentriMag Ventricular Assist System
Arm/Group Description	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.
Overall Participants	32
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (13.8)
Sex: Female, Male (Count of Participants)
Female	8 25%
Male	24 75%
Medical History (Count of Participants)
Smoking	14 43.8%
Diabetes	12 37.5%
Hyperlipidemia	16 50%
Prior Cardiovascular Events	29 90.6%
Ethnicity/Race (Count of Participants)
African American	4 12.5%
Asian	0 0%
Hispanic	2 6.3%
Native American	0 0%
White	24 75%
Other	2 6.3%
Heart Rate (beats per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats per minute]	91.1 (21.4)
Laboratory Values (mg/dl) [Mean (Standard Deviation) ]
Blood Urea Nitrogen	39.1 (21.3)
Creatinine	1.8 (0.8)
Total Bilirubin	1.8 (1.8)
Plasma Free Hemoglobin	28.8 (28.9)
Hemodynamic Values (mmHg) [Mean (Standard Deviation) ]
Systolic Blood Pressure	98.6 (23.2)
Diastolic Blood Pressure	54.2 (12.7)
Pulmonary Artery Systolic	37.3 (14.0)
Pulmonary Artery Diastolic	22.9 (8.5)
Central Venous Pressure	16.3 (8.0)
Glasgow Coma Scale (Count of Participants)
Eye Opening : Not done	2 6.3%
Eye Opening : No response	17 53.1%
Eye Opening : Response to speech	3 9.4%
Eye Opening : Spontaneous eye opening	10 31.3%
Motor response: Not done	2 6.3%
Motor response: No response to pain	13 40.6%
Motor response: Withdrawal to pain stimuli	2 6.3%
Motor response: Localizes pain	1 3.1%
Motor response: Obeys commands	14 43.8%
Verbal response: Not done	2 6.3%
Verbal response: No verbalization	19 59.4%
Verbal response: Normal conversation	11 34.4%
Body Surface Area (Meters squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Meters squared]	2.05 (0.25)
Cardiac Index (L/min/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [L/min/m^2]	1.6 (0.4)
Cardiac Output (L/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [L/min]	3.9 (1.3)
Respiratory Rate (Breaths per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Breaths per minute]	17.6 (6.5)

Outcome Measures

1. Primary Outcome

Title	Survival
Description	Number of patients alive 30 days after device implantation
Time Frame	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Supported by the CentriMag Ventricular Assist System
Arm/Group Description	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.
Measure Participants	32
Count of Participants [Participants]	20 62.5%

2. Secondary Outcome

Title	Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)
Description	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.
Time Frame	Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP

Outcome Measure Data

Analysis Population Description

measurements not made in all subjects

Arm/Group Title	Subjects Supported With CentriMag
Arm/Group Description
Measure Participants	32
CVP	-5.5 (4.1)
Mean arterial pressure	7.7 (11.9)

Adverse Events

Time Frame	From CentriMag implant, during support, and for 6 months post device-removal
Arm/Group Title	Patients Supported by the CentriMag Ventricular Assist System
Arm/Group Description	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.
All Cause Mortality
	Patients Supported by the CentriMag Ventricular Assist System
	Affected / at Risk (%)	# Events
Total	15/32 (46.9%)
Serious Adverse Events
	Patients Supported by the CentriMag Ventricular Assist System
	Affected / at Risk (%)	# Events
Total	32/32 (100%)
Blood and lymphatic system disorders
Major bleeding	26/32 (81.3%)	73
Hemolysis	4/32 (12.5%)	4
Venous thromboembolism	1/32 (3.1%)	1
Cardiac disorders
Cardiac arrhythmias	11/32 (34.4%)	13
Pericardial fluid collection	0/32 (0%)	0
Hypertension	1/32 (3.1%)	1
Myocardial infarction	0/32 (0%)	0
Right heart failure	2/32 (6.3%)	2
General disorders
Other adverse event	6/32 (18.8%)	7
Hepatobiliary disorders
Hepatic dysfunction	1/32 (3.1%)	1
Infections and infestations
Major infection	13/32 (40.6%)	22
Nervous system disorders
Neurologic dysfunction	0/32 (0%)	0
Psychiatric disorders
Psychiatric episode	2/32 (6.3%)	2
Renal and urinary disorders
Renal dysfunction	7/32 (21.9%)	7
Respiratory, thoracic and mediastinal disorders
Respiratory failure	14/32 (43.8%)	14
Skin and subcutaneous tissue disorders
Wound dehiscence	1/32 (3.1%)	1
Vascular disorders
Arterial non-CNS thromboembolism	1/32 (3.1%)	1
Other (Not Including Serious) Adverse Events
	Patients Supported by the CentriMag Ventricular Assist System
	Affected / at Risk (%)	# Events
Total	0/32 (0%)
General disorders
Other adverse events	0/32 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

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.