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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ongoing HM3 CE Mark study patients | The study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long term follow-up | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Subject outcomes and survival over time | At 5 years post HM3 CE Mark study implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 5 years post HM3 CE Mark study implant |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient does not consent to the continued data collection.
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Patients with advanced refractory left ventricular heart failure who were implanted with HeartMate 3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Gazzola, B. Sc. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital | Melbourne | Victoria | 3000 | Australia | ||
| AKH Medical University of Vienna |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival | Subject outcomes and survival over time | Posted | Number | 95% Confidence Interval | percentage of patients who survived | At 5 years post HM3 CE Mark study implant |
|
|
Events were collected as of 2 to 5 Years follow-up post implant
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ongoing HM3 CE Mark Study Patients | Ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pump Thrombosis | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Poornima Sood | Abbott | +17818528334 | poornima.sood@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2016 | Feb 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| At 5 years post HM3 CE Mark study implant |
| 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. | At 5 years post HM3 CE Mark study implant |
| Adverse Events | Number of Participants with Adverse Events | Between 2 and 5 years post HM3 CE Mark study implant |
| Device Malfunctions | Number of Participants with device malfunctions | Between 2 and 5 years post HM3 CE Mark study implant |
| Reoperations | Number of reoperations | Between 2 and 5 years post HM3 CE Mark study implant |
| Rehospitalizations | Number of rehospitalizations | Between 2 and 5 years post HM3 CE Mark study implant |
| 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 | As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first |
| Vienna |
| A-1090 |
| Austria |
| Toronto General Hospital | Toronto | Ontario | M5G2C4 | Canada |
| Institute for Clinical and Experimental Medicine (IKEM) | Prague | 4 | Czechia |
| Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany |
| Universitats-Herzzentrum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| National Research Center for Cardiac Surgery | Astana | 010000 | Kazakhstan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Surface Area (BSA) | Mean | Standard Deviation | m^2 |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Ischemic Etiology | Count of Participants | Participants |
|
| Indication for Left Ventricular Assist Device (LVAD) implant | Count of Participants | Participants |
|
| INTERMACS Profile | INTERMACS profiles are scaled depending on the patients condition from 7 (clinically stable with a reasonable level of comfortable activity) to 1 (critical cardiogenic shock) | Count of Participants | Participants |
|
| Cardiac Index | Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA), thus relating heart performance to the size of the individual. | Mean | Standard Deviation | l/min/m^2 |
|
| Left Ventricular Ejection Fraction (LVEF) | The ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid (usually blood) ejected from a chamber (usually the heart) with each contraction (or heartbeat). The left ventricular ejection fraction (LVEF), is calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume). LVEF is an indicator of the effectiveness of pumping into the systemic circulation. | Mean | Standard Deviation | percentage |
|
| Central Venous Pressure (CVP) | Mean | Standard Deviation | mmHg |
|
| Arterial Blood Pressure | The systolic pressure is the pressure during the heart contraction phase (systole) The mean arterial pressure is an average blood pressure in an individual during a single cardiac cycle The diastolic pressure is the pressure during the heart relaxation phase (diastole) | Mean | Standard Deviation | mmHg |
|
| Pulmonary Artery Pressure | The systolic pressure is the pressure during the heart contraction phase (systole) The mean arterial pressure is an average blood pressure in an individual during a single cardiac cycle The diastolic pressure is the pressure during the heart relaxation phase (diastole) | Mean | Standard Deviation | mmHg |
|
| Pulmonary Capillary Pressure | Mean | Standard Deviation | mmHg |
|
| White Blood Cell count | Mean | Standard Deviation | 10^3 cells/ml |
|
| Plasma-free Hemoglobin | Mean | Standard Deviation | mg/dl |
|
| International Normalized Ratio (INR) | The INR is the ratio of a patient's prothrombin time to a normal (control) sample, raised to the power of the ISI (International Sensitivity Index) value for the analytical system being used | Mean | Standard Deviation | ratio |
|
| Prothrombin time | Mean | Standard Deviation | s |
|
| Partial thromboplastin time | Mean | Standard Deviation | s |
|
| Total Cholesterol | Mean | Standard Deviation | mmol/l |
|
| Lactic Dehydrogenase (LDH) | Mean | Standard Deviation | U/l |
|
| Medications | Count of Participants | Participants |
|
| Pre-operative Risk Factors | Count of Participants | 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 | The population analyzed is composed by patients for whom the EQ-5D-5L questionnaire was available | Posted | Mean | Standard Deviation | score on a scale | At 5 years post HM3 CE Mark study implant |
|
|
|
| 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 | The population analyzed is composed by patients for whom the 6MWT was available | Posted | Mean | Standard Deviation | meters | At 5 years post HM3 CE Mark study implant |
|
|
|
| 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. | The population analyzed is composed by patients for whom the NYHA class was available | Posted | Count of Participants | Participants | At 5 years post HM3 CE Mark study implant |
|
|
|
| Secondary | Adverse Events | Number of Participants with Adverse Events | Ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection. | Posted | Count of Participants | Participants | Between 2 and 5 years post HM3 CE Mark study implant |
|
|
|
| Secondary | Device Malfunctions | Number of Participants with device malfunctions | Posted | Number | participants | Between 2 and 5 years post HM3 CE Mark study implant |
|
|
|
| Secondary | Reoperations | Number of reoperations | Posted | Number | events | Between 2 and 5 years post HM3 CE Mark study implant |
|
|
|
| Secondary | Rehospitalizations | Number of rehospitalizations | Posted | Number | events | Between 2 and 5 years post HM3 CE Mark study implant |
|
|
|
| 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 | In 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed | Posted | Number | 95% Confidence Interval | percentage of participants | As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first |
|
|
|
| 3 |
| 25 |
| 13 |
| 25 |
| 0 |
| 25 |
| Bleeding | Vascular disorders | Systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Right Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Stroke, Hemorrhagic | Nervous system disorders | Systematic Assessment |
|
| Stroke, Ischemic | Nervous system disorders | Systematic Assessment |
|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Outflow Graft Thrombosis | Product Issues | Systematic Assessment |
|
| Other Neurological event | Nervous system disorders | Systematic Assessment |
|
| Pump Malfunction | Product Issues | Systematic Assessment |
|
| Psychiatric Episode | Nervous system disorders | Systematic Assessment |
|
| Hepatic Dysfunction | Hepatobiliary disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Pericardial Fluid Collection | Blood and lymphatic system disorders | Systematic Assessment |
|
| Other Adverse Event | Cardiac disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| NYHA Class IIIB |
|
| NYHA Class IV |
|
| Title |
|---|
| Measurements |
|---|
|
| Stroke, Hemorrhagic |
|
| Pump Thrombosis |
|
| Hemolysis |
|
| Right Heart Failure |
|
| Other Reoperation |
|
| Neurological Event |
|
| Renal Dysfunction |
|
| Respiratory Insufficiency |
|
| Right Heart Failure |
|
| Other Adverse Event |
|