Advanced Refractory Left Ventricular Heart Failure
Conditions
Keywords
Heart Failure, LVAS, Ventricular Dysfunction, Cardiomyopathy, Heart Disease, Cardiovascular Disease, Heart-assist devices, Thoratec Corporation
Brief summary
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
Detailed description
Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.
Interventions
DEVICEHeartMate 3 LVAS
Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Subject or legal representative has signed Informed Consent Form (ICF) 2. Age ≥ 18 years 3. BSA ≥ 1.2 m2 4. NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV 5. LVEF ≤ 25% 6. a) Inotrope dependent OR b) CI \< 2.2 L/min/m2, while not on inotropes and subjects must also meet one of the following: * On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond * Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days, 7. Females of child bearing age must agree to use adequate contraception
Exclusion criteria
1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy 2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator 3. Existence of ongoing mechanical circulatory support (MCS) other than IABP 4. Positive pregnancy test if of childbearing potential 5. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant 6. History of any organ transplant 7. Platelet count \< 100,000 x 103/L (\< 100,000/ml) 8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management 9. History of confirmed, untreated Abdominal Aortic Aneurysm (AAA) \> 5 cm in diameter within 6 months of enrollment 10. Presence of an active, uncontrolled infection 11. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the investigator will require based upon the patients' health status 12. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: * An INR ≥ 2.0 not due to anticoagulation therapy * Total bilirubin \> 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis * History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, and FEV1 \<50% predicted * Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention * History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid artery stenosis * Serum Creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy * Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration 13. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant 14. Pre albumin \< 150 mg/L (15mg/dL) or Albumin \< 30g/L (3 g/dL) (if only one available); pre albumin \< 150 mg/L (15mg/dL) and Albumin \< 30g/L (3 g/dL) (if both available) 15. Planned Bi-VAD support prior to enrollment 16. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia 17. Participation in any other clinical investigation that is likely to confound study results or affect the study 18. Any condition other than HF that could limit survival to less than 24 months 19. Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free Survival | Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. | Survival at 24 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test (6MWT) | Baseline, 6 months and 24 months | Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging. |
| New York Heart Association (NYHA) Classification | Baseline, 6 months and 24 months | Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort. |
| EuroQol-5D-5L Visual Analogue Scale | Baseline, 6 months and 24 months | Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life. |
| Pump Replacement | As they occur up to 24 months or to outcome, whichever occurs first | Frequency of HeartMate 3 pump replacement at 24 months. |
| Rehospitalizations | From initial discharge to 2 years post-implant | Rate of all cause rehospitalization |
| Adverse Event Rates | 2 years post-implant | Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Baseline, 6 months and 24 months | Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HeartMate 3 LVAS (HM3 LVAS) The study will be a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.
HeartMate 3 LVAS: Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study. | 1,685 |
| Total | 1,685 |
Baseline characteristics
| Characteristic | HeartMate 3 LVAS (HM3 LVAS) |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 12.2 |
| Intended Goal of Support Bridge to Candidacy | 233 Participants |
| Intended Goal of Support Bridge to Recovery | 4 Participants |
| Intended Goal of Support Bridge to Transplant | 173 Participants |
| Intended Goal of Support Destination Therapy | 1274 Participants |
| Intended Goal of Support Rescue Therapy | 1 Participants |
| INTERMACS Profile 1 | 69 Participants |
| INTERMACS Profile 2 | 517 Participants |
| INTERMACS Profile 3 | 843 Participants |
| INTERMACS Profile 4 | 216 Participants |
| INTERMACS Profile 5 | 24 Participants |
| INTERMACS Profile 6 or 7 | 1 Participants |
| INTERMACS Profile Not provided | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants |
| Race (NIH/OMB) Black or African American | 466 Participants |
| Race (NIH/OMB) More than one race | 53 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 1135 Participants |
| Sex: Female, Male Female | 343 Participants |
| Sex: Female, Male Male | 1342 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 293 / 1,685 |
| other Total, other adverse events | 1,050 / 1,685 |
| serious Total, serious adverse events | 1,536 / 1,685 |
Outcome results
Primary
Event-Free Survival
Survival at 24 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Time frame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Event-Free Survival | 1320 Participants |
Secondary
Adverse Event Rates
Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Time frame: 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Other Neurological Event | 0.09 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Arterial Non-CNS Thromboembolism | 0.01 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Bleeding | 0.71 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Cardiac Arrhythmia | 0.30 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Hepatic Dysfunction | 0.04 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Hypertension | 0.04 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Major Infection | 0.73 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Myocardial Infarction | 0.01 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Stroke | 0.07 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Pericardial Fluid Collection | 0.04 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Psychiatric Episode | 0.07 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Renal Dysfunction | 0.11 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Respiratory Failure | 0.16 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Right Heart Failure | 0.27 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Venous Thromboembolism | 0.03 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Wound Dehiscence | 0.00 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Suspected Device Thrombosis | 0.01 events per patient year |
| HeartMate 3 LVAS (HM3 LVAS) | Adverse Event Rates | Hemolysis | 0.00 events per patient year |
Secondary
EuroQol-5D-5L Visual Analogue Scale
Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.
Time frame: Baseline, 6 months and 24 months
Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | EuroQol-5D-5L Visual Analogue Scale | Baseline | 48.3 score on a scale | Standard Deviation 25.1 |
| HeartMate 3 LVAS (HM3 LVAS) | EuroQol-5D-5L Visual Analogue Scale | 6 months | 73.9 score on a scale | Standard Deviation 18.2 |
| HeartMate 3 LVAS (HM3 LVAS) | EuroQol-5D-5L Visual Analogue Scale | 24 months | 72.4 score on a scale | Standard Deviation 20.1 |
Secondary
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time frame: Baseline, 6 months and 24 months
Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Baseline | 40.0 Score on a scale | Standard Deviation 21.6 |
| HeartMate 3 LVAS (HM3 LVAS) | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 6 months | 69.5 Score on a scale | Standard Deviation 20 |
| HeartMate 3 LVAS (HM3 LVAS) | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 24 months | 67.3 Score on a scale | Standard Deviation 21.8 |
Secondary
New York Heart Association (NYHA) Classification
Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.
Time frame: Baseline, 6 months and 24 months
Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | New York Heart Association (NYHA) Classification | NYHA Class I or II at Baseline | 0 Participants |
| HeartMate 3 LVAS (HM3 LVAS) | New York Heart Association (NYHA) Classification | Class I or II at 6 Months | 1046 Participants |
| HeartMate 3 LVAS (HM3 LVAS) | New York Heart Association (NYHA) Classification | Class I or II at 24 Months | 686 Participants |
Secondary
Pump Replacement
Frequency of HeartMate 3 pump replacement at 24 months.
Time frame: As they occur up to 24 months or to outcome, whichever occurs first
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Pump Replacement | 20 Participants |
Secondary
Rehospitalizations
Rate of all cause rehospitalization
Time frame: From initial discharge to 2 years post-implant
Population: Subjects who were discharged on LVAD support from the implant hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Rehospitalizations | 2.03 events per patient year |
Secondary
Six Minute Walk Test (6MWT)
Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.
Time frame: Baseline, 6 months and 24 months
Population: Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment. Patients unable to walk due to heart failure symptoms were assigned a distance of zero.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Six Minute Walk Test (6MWT) | Baseline | 101.3 meters | Standard Deviation 160.7 |
| HeartMate 3 LVAS (HM3 LVAS) | Six Minute Walk Test (6MWT) | 6 months | 317.2 meters | Standard Deviation 163.3 |
| HeartMate 3 LVAS (HM3 LVAS) | Six Minute Walk Test (6MWT) | 24 months | 305.1 meters | Standard Deviation 172.5 |