Advanced Refractory Left Ventricular Heart Failure
Conditions
Keywords
Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Disease, Cardiovascular Disease, Heart-assist Devices, Thoratec Corporation
Brief summary
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.
Interventions
OTHERLong term follow-up
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient or legal representative has signed Informed Consent Form (ICF). 2. Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.
Exclusion criteria
1\. Patient does not consent to the continued data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | At 5 years post HM3 CE Mark study implant | Subject outcomes and survival over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalizations | Between 2 and 5 years post HM3 CE Mark study implant | Number of rehospitalizations |
| Device Malfunctions | Between 2 and 5 years post HM3 CE Mark study implant | Number of Participants with device malfunctions |
| EuroQoL 5D-5L (EQ-5D-5L) VAS Score | At 5 years post HM3 CE Mark study implant | Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life |
| Reoperations | Between 2 and 5 years post HM3 CE Mark study implant | Number of reoperations |
| New York Heart Association (NYHA) | At 5 years post HM3 CE Mark study implant | Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms: I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
| Adverse Events | Between 2 and 5 years post HM3 CE Mark study implant | Number of Participants with Adverse Events |
| Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3) | As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first | Modified Rankin Score \>3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed. The MRS scale is as following: 0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead |
| Six Minute Walk Test (6MWT) | At 5 years post HM3 CE Mark study implant | Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes |
Countries
Australia, Austria, Canada, Czechia, Germany, Kazakhstan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ongoing HM3 CE Mark Study Patients Patients who were ongoing after two years follow-up in the HeartMate 3 CE Mark study (NCT02170363) and consented to participate in long-term follow-up data collection. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | Ongoing HM3 CE Mark Study Patients | — |
|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 13.2 | — |
| Arterial Blood Pressure Diastolic pressure | 23.1 mmHg STANDARD_DEVIATION 9.5 | — |
| Arterial Blood Pressure Mean pressure | 77.5 mmHg STANDARD_DEVIATION 8.6 | — |
| Arterial Blood Pressure Systolic pressure | 105.3 mmHg STANDARD_DEVIATION 11.7 | — |
| Body Mass Index (BMI) | 27.3 kg/m^2 STANDARD_DEVIATION 4.7 | — |
| Body Surface Area (BSA) | 2.0 m^2 STANDARD_DEVIATION 0.2 | — |
| Cardiac Index | 1.7 l/min/m^2 STANDARD_DEVIATION 0.34 | — |
| Central Venous Pressure (CVP) | 9.3 mmHg STANDARD_DEVIATION 5.01 | — |
| Indication for Left Ventricular Assist Device (LVAD) implant Bridge to cardiac transplantation (BTT) | 14 Participants | — |
| Indication for Left Ventricular Assist Device (LVAD) implant Permanent destination therapy (DT) | 11 Participants | — |
| INTERMACS Profile Profile 1 | 0 Participants | — |
| INTERMACS Profile Profile 2 | 1 Participants | — |
| INTERMACS Profile Profile 3 | 9 Participants | — |
| INTERMACS Profile Profile 4 | 14 Participants | — |
| INTERMACS Profile Profile 5 | 1 Participants | — |
| INTERMACS Profile Profile 6 | 0 Participants | — |
| INTERMACS Profile Profile 7 | 0 Participants | — |
| International Normalized Ratio (INR) | 1.36 ratio STANDARD_DEVIATION 0.5 | — |
| Ischemic Etiology | 11 Participants | — |
| Lactic Dehydrogenase (LDH) | 4.0 U/l STANDARD_DEVIATION 1 | — |
| Left Ventricular Ejection Fraction (LVEF) | 19.4 percentage STANDARD_DEVIATION 3.7 | — |
| Medications ACE Inhibitor | 12 Participants | — |
| Medications Angiotensin II antagonist | 5 Participants | — |
| Medications Antiarrhythmic drug | 11 Participants | — |
| Medications Anticoagulant/antiplatelet drug | 23 Participants | — |
| Medications Beta-blocker | 17 Participants | — |
| Medications Inotropes type 1 | 7 Participants | — |
| Medications Inotropes type 2 | 5 Participants | — |
| Partial thromboplastin time | 38.9 s STANDARD_DEVIATION 5.8 | — |
| Plasma-free Hemoglobin | 13.8 mg/dl STANDARD_DEVIATION 16.3 | — |
| Pre-operative Risk Factors Arrhythmia | 19 Participants | — |
| Pre-operative Risk Factors Diabetes | 6 Participants | — |
| Pre-operative Risk Factors Hypertension | 17 Participants | — |
| Pre-operative Risk Factors Left ventricular aneurism | 3 Participants | — |
| Pre-operative Risk Factors Pacemaker/defibrillator | 19 Participants | — |
| Pre-operative Risk Factors Peripheral vascular disease | 2 Participants | — |
| Pre-operative Risk Factors Prior sternotomy | 6 Participants | — |
| Pre-operative Risk Factors Renal Dysfunction | 12 Participants | — |
| Pre-operative Risk Factors Severe Chronic Obstructive Pulmonary Disease (COPD) | 1 Participants | — |
| Pre-operative Risk Factors Stroke | 1 Participants | — |
| Pre-operative Risk Factors Transient Ischemic Attack (TIA) | 3 Participants | — |
| Pre-operative Risk Factors Valve disease | 21 Participants | — |
| Prothrombin time | 15.7 s STANDARD_DEVIATION 4.6 | — |
| Pulmonary Artery Pressure Diastolic | 23.1 mmHg STANDARD_DEVIATION 9.5 | — |
| Pulmonary Artery Pressure Mean | 33.7 mmHg STANDARD_DEVIATION 13.3 | — |
| Pulmonary Artery Pressure Systolic | 51.8 mmHg STANDARD_DEVIATION 20.8 | — |
| Pulmonary Capillary Pressure | 22.2 mmHg STANDARD_DEVIATION 10.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 1 participants | — |
| Region of Enrollment Austria | 2 participants | — |
| Region of Enrollment Canada | 2 participants | — |
| Region of Enrollment Czechia | 7 participants | — |
| Region of Enrollment Germany | 9 participants | — |
| Region of Enrollment Kazakhstan | 4 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
| Total Cholesterol | 4.1 mmol/l STANDARD_DEVIATION 1.4 | — |
| White Blood Cell count | 7.2 10^3 cells/ml STANDARD_DEVIATION 1.9 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 13 / 25 |
Outcome results
Primary
Survival
Subject outcomes and survival over time
Time frame: At 5 years post HM3 CE Mark study implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ongoing HM3 CE Mark Study Patients | Survival | 61 percentage of patients who survived |
Secondary
Adverse Events
Number of Participants with Adverse Events
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Population: Ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | Adverse Events | Right Heart Failure | 1 Participants |
| Ongoing HM3 CE Mark Study Patients | Adverse Events | Bleeding | 3 Participants |
| Ongoing HM3 CE Mark Study Patients | Adverse Events | Infection | 9 Participants |
| Ongoing HM3 CE Mark Study Patients | Adverse Events | Stroke, Ischemic | 2 Participants |
| Ongoing HM3 CE Mark Study Patients | Adverse Events | Stroke, Hemorrhagic | 3 Participants |
| Ongoing HM3 CE Mark Study Patients | Adverse Events | Pump Thrombosis | 0 Participants |
| Ongoing HM3 CE Mark Study Patients | Adverse Events | Hemolysis | 0 Participants |
Secondary
Device Malfunctions
Number of Participants with device malfunctions
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ongoing HM3 CE Mark Study Patients | Device Malfunctions | 0 participants |
Secondary
EuroQoL 5D-5L (EQ-5D-5L) VAS Score
Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life
Time frame: At 5 years post HM3 CE Mark study implant
Population: The population analyzed is composed by patients for whom the EQ-5D-5L questionnaire was available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | EuroQoL 5D-5L (EQ-5D-5L) VAS Score | 69.3 score on a scale | Standard Deviation 19.3 |
Secondary
New York Heart Association (NYHA)
Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms: I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: At 5 years post HM3 CE Mark study implant
Population: The population analyzed is composed by patients for whom the NYHA class was available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | New York Heart Association (NYHA) | NYHA Class I | 9 Participants |
| Ongoing HM3 CE Mark Study Patients | New York Heart Association (NYHA) | NYHA Class II | 10 Participants |
| Ongoing HM3 CE Mark Study Patients | New York Heart Association (NYHA) | NYHA Class IIIA | 2 Participants |
| Ongoing HM3 CE Mark Study Patients | New York Heart Association (NYHA) | NYHA Class IIIB | 0 Participants |
| Ongoing HM3 CE Mark Study Patients | New York Heart Association (NYHA) | NYHA Class IV | 0 Participants |
Secondary
Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)
Modified Rankin Score \>3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed. The MRS scale is as following: 0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead
Time frame: As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Population: In 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3) | Assuming three patients with missing MRS had debilitating stroke | 55.1 percentage of participants |
| Ongoing HM3 CE Mark Study Patients | Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3) | Assuming three patients with missing MRS had non-debilitating stroke | 61.0 percentage of participants |
Secondary
Rehospitalizations
Number of rehospitalizations
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Neurological Event | 2 events |
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Renal Dysfunction | 1 events |
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Respiratory Insufficiency | 0 events |
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Cardiac Arrhythmia | 1 events |
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Infection | 19 events |
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Bleeding | 2 events |
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Right Heart Failure | 1 events |
| Ongoing HM3 CE Mark Study Patients | Rehospitalizations | Other Adverse Event | 13 events |
Secondary
Reoperations
Number of reoperations
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | Reoperations | Major bleeding | 1 events |
| Ongoing HM3 CE Mark Study Patients | Reoperations | Major infection | 6 events |
| Ongoing HM3 CE Mark Study Patients | Reoperations | Neurologic dysfunction | 4 events |
| Ongoing HM3 CE Mark Study Patients | Reoperations | Other Reoperation | 11 events |
Secondary
Six Minute Walk Test (6MWT)
Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes
Time frame: At 5 years post HM3 CE Mark study implant
Population: The population analyzed is composed by patients for whom the 6MWT was available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | Six Minute Walk Test (6MWT) | 294.4 meters | Standard Deviation 155.8 |