Heart Failure
Conditions
Keywords
Heart Failure
Brief summary
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure
Detailed description
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure. The primary endpoint is survival at 6 months presented as a simple proportion (subjects alive on the MVAD® pump divided by endpoint eligible subjects). Secondary endpoints include the incidence of bleeding, incidence of major infections (per INTERMACS definitions), time to death, incidence of all device failures and device malfunctions, Health Status improvement, and Functional status improvement. Safety measures will include the frequency and rates of adverse events, overall and for each specific event, which will be collected throughout VAD support.
Interventions
DEVICEHeartWare MVAD® System
The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
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
1. Must be ≥18 years of age at consent 2. Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following): 1. on optimal medical management including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or 2. in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes. 3. Left ventricular ejection fraction ≤25%. 4. Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study. 5. The subject has signed the informed consent form.
Exclusion criteria
1. Body Mass Index (BMI) \> 47. 2. Body Surface Area (BSA) \< 1.0 m2. 3. Partial or full mechanical circulatory support within thirty days of implant. 4. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA®. 5. Prior cardiac transplant or cardiomyoplasty. 6. History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter \> 5 cm). 7. Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities. 8. On ventilator support for \> 72 hours within the four days immediately prior to implant. 9. Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan. 10. Symptomatic cerebrovascular disease, stroke within 180 days of implant or \> 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation 11. Uncorrected moderate to severe aortic insufficiency. 12. Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening. 13. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment. 14. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count \< 75,000, International Normalized Ratio (INR) \> 2.0 or Partial Thromboplastin Time (PTT) \> 2.5 times control in the absence of anticoagulation therapy). 15. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the subject's health status. 16. Serum creatinine \> 3.0 mg/dL within 72 hours of implant or requiring dialysis. 17. Specific liver enzymes \[Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)\] \> 3 times upper limit of normal within 72 hours of implant. 18. A total bilirubin \> 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension. 19. Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation. 20. Subjects with a mechanical heart valve. 21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy. 22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 \< 50% predicted value). 23. Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial. 24. Severe illness, other than heart disease, which would limit survival to \< 3 years. 25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities. 26. Pregnancy and breast feeding. 27. Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD. 28. Subject unwilling or unable to comply with trial requirements. 29. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator. 30. Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members or employees of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Six month | Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival: Number of Participants Who Died by Six Months and Two Years | Six months and two years | Survival: Number of participants who died by six months and two years |
| Incidence of Major Bleeding | Six months and two years | Incidence of major bleeding, per INTERMACS definition |
| Incidence of All Device Failures and Device Malfunctions | Six months and two years | Incidence of all device failures and device malfunctions per INTERMACS definition |
| Incidence of Major Infection | Six months and two years | Incidence of major infection, per INTERMACS definition |
| Incidence of Neurological Dysfunction | Six months and two years | Incidence of neurological dysfunction per INTERMACS definition |
| Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | Six month and 24 month visit | Health Status change, as measured by KCCQ and EuroQol EQ-5D-5L. Measured at baseline, 6 month visit and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured. The EQ-5D-5L overall score is between 0 and 1. 1 being the best score and 0 being the worst score. The KCCQ score is between 0 and 100. 100 being the best score and 0 being the worst score. |
| Functional Status Change, as Measured 6-minute Walk | 6 month and 24 month visit | Functional status change, as measured by 6-minute walk. Distance walked in meters in 6 minutes measured at baseline, 6 months and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured |
| Survival | Two years | Survival at 24 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 24 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure. |
| Length of Initial Hospital Stay (Days) | Post operation | Length of Initial hospital stay (days) from procedure start to discharge |
| Re-Hospitalizations | On or before 6 months follow-up and 24 month follow-up | The length of Re-Hospitalization, excluding planned procedures, stay in days. |
| Transplantations | Six months and two years | Transplantations of subjects enrolled in study and implanted with MVAD System |
| Explants | Six months and two years | Explants (i.e. death, transplant, recovery, device exchange) of MVAD in subjects enrolled in study and implanted with MVAD System |
| New York Heart Association (NYHA) Functional Classification Score | Baseline and 6 month and 24 month visit | NYHA score measured at baseline, 6 month visit and 24 month visit. The NYHA scale is from I to IV. A subject with a score of IV indicates more severe heart failure than a subject with a score of I. Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort |
| Length of Operative Time (Hours) | Implant | Length of operative time (hours) |
| Frequency and Rates of Adverse Events(AEs) | Six months and two years | Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition |
Countries
Australia, Austria, France, Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MVAD® Pump Implant of HeartWare MVAD® System
HeartWare MVAD® System: The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Still on original MVAD device | 2 |
Baseline characteristics
| Characteristic | MVAD® Pump |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 14.53 |
| Blood Pressure Diastolic | 65.9 mmHg STANDARD_DEVIATION 10.1 |
| Blood Pressure Systolic | 101 mmHg STANDARD_DEVIATION 15.58 |
| Body Mass Index | 23.2 kg/m^2 STANDARD_DEVIATION 3.41 |
| Body Surface Area | 1.9 m^2 STANDARD_DEVIATION 0.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 177.3 centimeters STANDARD_DEVIATION 6.41 |
| Intermacs Patient Profile 1 - Critical cardiogenic shock | 0 participants |
| Intermacs Patient Profile 2 - Progressive decline | 0 participants |
| Intermacs Patient Profile 3 - Inotrope dependent | 6 participants |
| Intermacs Patient Profile 4 - Resting symptoms | 5 participants |
| Intermacs Patient Profile 5 - Exertion intolerant | 0 participants |
| Intermacs Patient Profile 6 - Exertion limited | 0 participants |
| Intermacs Patient Profile 7 - Advanced NYHA III | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment Australia | 2 participants |
| Region of Enrollment Austria | 2 participants |
| Region of Enrollment Germany | 5 participants |
| Region of Enrollment United Kingdom | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight | 73.5 kilograms STANDARD_DEVIATION 14.36 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 10 / 11 |
| serious Total, serious adverse events | 7 / 11 |
Outcome results
Primary
Survival
Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Time frame: Six month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVAD® Pump | Survival | 10 Participants |
Secondary
Explants
Explants (i.e. death, transplant, recovery, device exchange) of MVAD in subjects enrolled in study and implanted with MVAD System
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Explants | Subjects with Explants by 6 months, cumulative | 1 Participants |
| MVAD® Pump | Explants | Subjects with Explants by 2 years, cumulative | 5 Participants |
Secondary
Frequency and Rates of Adverse Events(AEs)
Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Frequency and Rates of Adverse Events(AEs) | Subjects with First Adverse Event by 6 months, cumulative. | 11 Participants |
| MVAD® Pump | Frequency and Rates of Adverse Events(AEs) | Subjects with first Adverse Event by 2 years, cumulative. | 11 Participants |
Secondary
Functional Status Change, as Measured 6-minute Walk
Functional status change, as measured by 6-minute walk. Distance walked in meters in 6 minutes measured at baseline, 6 months and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured
Time frame: 6 month and 24 month visit
Population: Subjects with implant attempt
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MVAD® Pump | Functional Status Change, as Measured 6-minute Walk | Baseline | 257.83 Distance in meters | Standard Deviation 93.7 |
| MVAD® Pump | Functional Status Change, as Measured 6-minute Walk | 6 month visit | 445.4 Distance in meters | Standard Deviation 71.71 |
| MVAD® Pump | Functional Status Change, as Measured 6-minute Walk | Change between 6 month visit and baseline | 213 Distance in meters | Standard Deviation 81.97 |
| MVAD® Pump | Functional Status Change, as Measured 6-minute Walk | 2 year visit | 402 Distance in meters | Standard Deviation 74.95 |
| MVAD® Pump | Functional Status Change, as Measured 6-minute Walk | Change between 2 year visit and baseline | 313 Distance in meters | Standard Deviation 0 |
Secondary
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
Health Status change, as measured by KCCQ and EuroQol EQ-5D-5L. Measured at baseline, 6 month visit and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured. The EQ-5D-5L overall score is between 0 and 1. 1 being the best score and 0 being the worst score. The KCCQ score is between 0 and 100. 100 being the best score and 0 being the worst score.
Time frame: Six month and 24 month visit
Population: No data displayed because Outcome Measure has zero total participants analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | KCCQ Overall Score 24 Months | 81.94 Score | Standard Deviation 11.37 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | EQ5D Baseline | 0.63 Score | Standard Deviation 0.29 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | EQ5D 6 Months | 0.67 Score | Standard Deviation 0.34 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | EQ5D 6 Months vs baseline | 0.13 Score | Standard Deviation 0.47 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | EQ5D at 24 Months | 0.94 Score | Standard Deviation 0.11 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | EQ5D 24 Months vs baseline | 0.21 Score | Standard Deviation 0.31 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | KCCQ Overall Score Baseline | 47.86 Score | Standard Deviation 21.79 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | KCCQ Overall Score 6 Months | 72.63 Score | Standard Deviation 16.1 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | KCCQ Overall Score 6 Months vs Baseline | 22.49 Score | Standard Deviation 31.16 |
| MVAD® Pump | Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L | KCCQ Overall Score 24 Months vs Baseline | 23.5 Score | Standard Deviation 35.15 |
Secondary
Incidence of All Device Failures and Device Malfunctions
Incidence of all device failures and device malfunctions per INTERMACS definition
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Incidence of All Device Failures and Device Malfunctions | Subjects with Device Malfunction by 2 years, cumulative | 6 Participants |
| MVAD® Pump | Incidence of All Device Failures and Device Malfunctions | Subjects with Device Malfunction by 6 months, cumulative | 5 Participants |
Secondary
Incidence of Major Bleeding
Incidence of major bleeding, per INTERMACS definition
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Incidence of Major Bleeding | Subjects who had an incidence of major bleeding by 6 months, cumulative | 5 Participants |
| MVAD® Pump | Incidence of Major Bleeding | Subjects who had an incidence of major bleeding by 2 years, cumulative | 7 Participants |
Secondary
Incidence of Major Infection
Incidence of major infection, per INTERMACS definition
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Incidence of Major Infection | Subjects with Major Infection by 6 months, cumulative | 3 Participants |
| MVAD® Pump | Incidence of Major Infection | Subjects with Major Infection by 2 years, cumulative | 5 Participants |
Secondary
Incidence of Neurological Dysfunction
Incidence of neurological dysfunction per INTERMACS definition
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Incidence of Neurological Dysfunction | Subjects with Neurological Dysfunction by 6 months, cumulative | 0 Participants |
| MVAD® Pump | Incidence of Neurological Dysfunction | Subjects with Neurological Dysfunction by 2 years, cumulative | 0 Participants |
Secondary
Length of Initial Hospital Stay (Days)
Length of Initial hospital stay (days) from procedure start to discharge
Time frame: Post operation
Population: Subjects who underwent an MVAD implant attempt
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVAD® Pump | Length of Initial Hospital Stay (Days) | 40.2 Days | Standard Deviation 15.56 |
Secondary
Length of Operative Time (Hours)
Length of operative time (hours)
Time frame: Implant
Population: Subjects who underwent an MVAD implant attempt
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVAD® Pump | Length of Operative Time (Hours) | 2.78 Hours | Standard Deviation 0.53 |
Secondary
New York Heart Association (NYHA) Functional Classification Score
NYHA score measured at baseline, 6 month visit and 24 month visit. The NYHA scale is from I to IV. A subject with a score of IV indicates more severe heart failure than a subject with a score of I. Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort
Time frame: Baseline and 6 month and 24 month visit
Population: Subjects implanted with MVAD
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | New York Heart Association (NYHA) Functional Classification Score | Class I | 0 Participants |
| MVAD® Pump | New York Heart Association (NYHA) Functional Classification Score | Class III | 6 Participants |
| MVAD® Pump | New York Heart Association (NYHA) Functional Classification Score | Class IV | 5 Participants |
| MVAD® Pump | New York Heart Association (NYHA) Functional Classification Score | Class II | 0 Participants |
| MVAD Pump 6 Months | New York Heart Association (NYHA) Functional Classification Score | Class I | 3 Participants |
| MVAD Pump 6 Months | New York Heart Association (NYHA) Functional Classification Score | Class II | 4 Participants |
| MVAD Pump 6 Months | New York Heart Association (NYHA) Functional Classification Score | Class III | 0 Participants |
| MVAD Pump 6 Months | New York Heart Association (NYHA) Functional Classification Score | Class IV | 0 Participants |
| MVAD Pump at 24 Months | New York Heart Association (NYHA) Functional Classification Score | Class III | 0 Participants |
| MVAD Pump at 24 Months | New York Heart Association (NYHA) Functional Classification Score | Class I | 3 Participants |
| MVAD Pump at 24 Months | New York Heart Association (NYHA) Functional Classification Score | Class II | 0 Participants |
| MVAD Pump at 24 Months | New York Heart Association (NYHA) Functional Classification Score | Class IV | 0 Participants |
Secondary
Re-Hospitalizations
The length of Re-Hospitalization, excluding planned procedures, stay in days.
Time frame: On or before 6 months follow-up and 24 month follow-up
Population: Subjects with an implant attempt
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MVAD® Pump | Re-Hospitalizations | Length of Hospital Stay up to 6 month visit | 34.82 Days | Standard Deviation 110.22 |
| MVAD® Pump | Re-Hospitalizations | Length of Hospital Stay Through 2 years | 69.91 Days | Standard Deviation 113.66 |
Secondary
Survival
Survival at 24 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 24 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Time frame: Two years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVAD® Pump | Survival | 10 Participants |
Secondary
Survival: Number of Participants Who Died by Six Months and Two Years
Survival: Number of participants who died by six months and two years
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Survival: Number of Participants Who Died by Six Months and Two Years | Subjects who died by 6 months, cumulative | 1 Participants |
| MVAD® Pump | Survival: Number of Participants Who Died by Six Months and Two Years | Subjects who died by 2 years, cumulative | 1 Participants |
Secondary
Transplantations
Transplantations of subjects enrolled in study and implanted with MVAD System
Time frame: Six months and two years
Population: The number of subjects enrolled in the study and implanted with MVAD System.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVAD® Pump | Transplantations | Subjects with transplant by 6 months, cumulative | 0 Participants |
| MVAD® Pump | Transplantations | Subjects with transplant by 2 years, cumulative | 3 Participants |