Heart Failure
Conditions
Keywords
Cardiac Dysfunction, Failure-to-wean from CPB, CentriMag, Levitronix, Thoratec Corporation
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.
Interventions
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.
Sponsors
Thoratec Corporation
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| CentriMag Ventricular Assist System 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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | CentriMag Ventricular Assist System |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 13.8 |
| Body Surface Area | 2.05 Meters squared STANDARD_DEVIATION 0.25 |
| Cardiac Index | 1.6 L/min/m^2 STANDARD_DEVIATION 0.4 |
| Cardiac Output | 3.9 L/min STANDARD_DEVIATION 1.3 |
| Ethnicity/Race African American | 4 Participants |
| Ethnicity/Race Asian | 0 Participants |
| Ethnicity/Race Hispanic | 2 Participants |
| Ethnicity/Race Native American | 0 Participants |
| Ethnicity/Race Other | 2 Participants |
| Ethnicity/Race White | 24 Participants |
| Glasgow Coma Scale Eye Opening : No response | 17 Participants |
| Glasgow Coma Scale Eye Opening : Not done | 2 Participants |
| Glasgow Coma Scale Eye Opening : Response to speech | 3 Participants |
| Glasgow Coma Scale Eye Opening : Spontaneous eye opening | 10 Participants |
| Glasgow Coma Scale Motor response: Localizes pain | 1 Participants |
| Glasgow Coma Scale Motor response: No response to pain | 13 Participants |
| Glasgow Coma Scale Motor response: Not done | 2 Participants |
| Glasgow Coma Scale Motor response: Obeys commands | 14 Participants |
| Glasgow Coma Scale Motor response: Withdrawal to pain stimuli | 2 Participants |
| Glasgow Coma Scale Verbal response: Normal conversation | 11 Participants |
| Glasgow Coma Scale Verbal response: Not done | 2 Participants |
| Glasgow Coma Scale Verbal response: No verbalization | 19 Participants |
| Heart Rate | 91.1 beats per minute STANDARD_DEVIATION 21.4 |
| Hemodynamic Values Central Venous Pressure | 16.3 mmHg STANDARD_DEVIATION 8 |
| Hemodynamic Values Diastolic Blood Pressure | 54.2 mmHg STANDARD_DEVIATION 12.7 |
| Hemodynamic Values Pulmonary Artery Diastolic | 22.9 mmHg STANDARD_DEVIATION 8.5 |
| Hemodynamic Values Pulmonary Artery Systolic | 37.3 mmHg STANDARD_DEVIATION 14 |
| Hemodynamic Values Systolic Blood Pressure | 98.6 mmHg STANDARD_DEVIATION 23.2 |
| Laboratory Values Blood Urea Nitrogen | 39.1 mg/dl STANDARD_DEVIATION 21.3 |
| Laboratory Values Creatinine | 1.8 mg/dl STANDARD_DEVIATION 0.8 |
| Laboratory Values Plasma Free Hemoglobin | 28.8 mg/dl STANDARD_DEVIATION 28.9 |
| Laboratory Values Total Bilirubin | 1.8 mg/dl STANDARD_DEVIATION 1.8 |
| Medical History Diabetes | 12 Participants |
| Medical History Hyperlipidemia | 16 Participants |
| Medical History Prior Cardiovascular Events | 29 Participants |
| Medical History Smoking | 14 Participants |
| Respiratory Rate | 17.6 Breaths per minute STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 32 / 32 |
Outcome results
Primary
Survival
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Supported by the CentriMag Ventricular Assist System | Survival | 20 Participants |
Secondary
Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (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.
Time frame: Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP
Population: measurements not made in all subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Supported by the CentriMag Ventricular Assist System | Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP) | CVP | -5.5 mmHg | Standard Deviation 4.1 |
| Patients Supported by the CentriMag Ventricular Assist System | Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP) | Mean arterial pressure | 7.7 mmHg | Standard Deviation 11.9 |