Trial Outcomes & Findings for HeartMate 3 CE Mark Study Long Term Follow-up (NCT NCT03022461)

NCT ID: NCT03022461

Last Updated: 2022-06-27

Results Overview

Subject outcomes and survival over time

• Recruitment status: COMPLETED
• Target enrollment: 25 participants
• Primary outcome timeframe: At 5 years post HM3 CE Mark study implant
• Results posted on: 2022-06-27

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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.
Overall Study Death	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ongoing HM3 CE Mark Study Patients n=25 Participants 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.
Age, Continuous	59.9 years STANDARD_DEVIATION 13.2 • n=25 Participants
Sex: Female, Male Female	4 Participants n=25 Participants
Sex: Female, Male Male	21 Participants n=25 Participants
Region of Enrollment Canada	2 participants n=25 Participants
Region of Enrollment Austria	2 participants n=25 Participants
Region of Enrollment Czechia	7 participants n=25 Participants
Region of Enrollment Kazakhstan	4 participants n=25 Participants
Region of Enrollment Australia	1 participants n=25 Participants
Region of Enrollment Germany	9 participants n=25 Participants
Body Surface Area (BSA)	2.0 m^2 STANDARD_DEVIATION 0.2 • n=25 Participants
Body Mass Index (BMI)	27.3 kg/m^2 STANDARD_DEVIATION 4.7 • n=25 Participants
Ischemic Etiology	11 Participants n=25 Participants
Indication for Left Ventricular Assist Device (LVAD) implant Bridge to cardiac transplantation (BTT)	14 Participants n=25 Participants
Indication for Left Ventricular Assist Device (LVAD) implant Permanent destination therapy (DT)	11 Participants n=25 Participants
INTERMACS Profile Profile 1	0 Participants n=25 Participants
INTERMACS Profile Profile 2	1 Participants n=25 Participants
INTERMACS Profile Profile 3	9 Participants n=25 Participants
INTERMACS Profile Profile 4	14 Participants n=25 Participants
INTERMACS Profile Profile 5	1 Participants n=25 Participants
INTERMACS Profile Profile 6	0 Participants n=25 Participants
INTERMACS Profile Profile 7	0 Participants n=25 Participants
Cardiac Index	1.7 l/min/m^2 STANDARD_DEVIATION 0.34 • n=25 Participants
Left Ventricular Ejection Fraction (LVEF)	19.4 percentage STANDARD_DEVIATION 3.7 • n=25 Participants
Central Venous Pressure (CVP)	9.3 mmHg STANDARD_DEVIATION 5.01 • n=25 Participants
Arterial Blood Pressure Systolic pressure	105.3 mmHg STANDARD_DEVIATION 11.7 • n=25 Participants
Arterial Blood Pressure Mean pressure	77.5 mmHg STANDARD_DEVIATION 8.6 • n=25 Participants
Arterial Blood Pressure Diastolic pressure	23.1 mmHg STANDARD_DEVIATION 9.5 • n=25 Participants
Pulmonary Artery Pressure Systolic	51.8 mmHg STANDARD_DEVIATION 20.8 • n=25 Participants
Pulmonary Artery Pressure Mean	33.7 mmHg STANDARD_DEVIATION 13.3 • n=25 Participants
Pulmonary Artery Pressure Diastolic	23.1 mmHg STANDARD_DEVIATION 9.5 • n=25 Participants
Pulmonary Capillary Pressure	22.2 mmHg STANDARD_DEVIATION 10.1 • n=25 Participants
White Blood Cell count	7.2 10^3 cells/ml STANDARD_DEVIATION 1.9 • n=25 Participants
Plasma-free Hemoglobin	13.8 mg/dl STANDARD_DEVIATION 16.3 • n=25 Participants
International Normalized Ratio (INR)	1.36 ratio STANDARD_DEVIATION 0.5 • n=25 Participants
Prothrombin time	15.7 s STANDARD_DEVIATION 4.6 • n=25 Participants
Partial thromboplastin time	38.9 s STANDARD_DEVIATION 5.8 • n=25 Participants
Total Cholesterol	4.1 mmol/l STANDARD_DEVIATION 1.4 • n=25 Participants
Lactic Dehydrogenase (LDH)	4.0 U/l STANDARD_DEVIATION 1.0 • n=25 Participants
Medications ACE Inhibitor	12 Participants n=25 Participants
Medications Angiotensin II antagonist	5 Participants n=25 Participants
Medications Beta-blocker	17 Participants n=25 Participants
Medications Anticoagulant/antiplatelet drug	23 Participants n=25 Participants
Medications Antiarrhythmic drug	11 Participants n=25 Participants
Medications Inotropes type 1	7 Participants n=25 Participants
Medications Inotropes type 2	5 Participants n=25 Participants
Pre-operative Risk Factors Hypertension	17 Participants n=25 Participants
Pre-operative Risk Factors Diabetes	6 Participants n=25 Participants
Pre-operative Risk Factors Prior sternotomy	6 Participants n=25 Participants
Pre-operative Risk Factors Severe Chronic Obstructive Pulmonary Disease (COPD)	1 Participants n=25 Participants
Pre-operative Risk Factors Transient Ischemic Attack (TIA)	3 Participants n=25 Participants
Pre-operative Risk Factors Stroke	1 Participants n=25 Participants
Pre-operative Risk Factors Renal Dysfunction	12 Participants n=25 Participants
Pre-operative Risk Factors Arrhythmia	19 Participants n=25 Participants
Pre-operative Risk Factors Pacemaker/defibrillator	19 Participants n=25 Participants
Pre-operative Risk Factors Valve disease	21 Participants n=25 Participants
Pre-operative Risk Factors Peripheral vascular disease	2 Participants n=25 Participants
Pre-operative Risk Factors Left ventricular aneurism	3 Participants n=25 Participants

PRIMARY outcome

Timeframe: At 5 years post HM3 CE Mark study implant

Subject outcomes and survival over time

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=25 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
Survival	61 percentage of patients who survived Interval 44.0 to 74.0

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=20 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
EuroQoL 5D-5L (EQ-5D-5L) VAS Score	69.3 score on a scale Standard Deviation 19.3

SECONDARY outcome

Timeframe: At 5 years post HM3 CE Mark study implant

Population: The population analyzed is composed by patients for whom the 6MWT was available

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

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=22 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
Six Minute Walk Test (6MWT)	294.4 meters Standard Deviation 155.8

SECONDARY outcome

Timeframe: At 5 years post HM3 CE Mark study implant

Population: The population analyzed is composed by patients for whom the NYHA class was available

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.

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=21 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
New York Heart Association (NYHA) NYHA Class I	9 Participants
New York Heart Association (NYHA) NYHA Class II	10 Participants
New York Heart Association (NYHA) NYHA Class IIIA	2 Participants
New York Heart Association (NYHA) NYHA Class IIIB	0 Participants
New York Heart Association (NYHA) NYHA Class IV	0 Participants

SECONDARY outcome

Timeframe: 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.

Number of Participants with Adverse Events

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=25 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
Adverse Events Bleeding	3 Participants
Adverse Events Infection	9 Participants
Adverse Events Stroke, Ischemic	2 Participants
Adverse Events Stroke, Hemorrhagic	3 Participants
Adverse Events Pump Thrombosis	0 Participants
Adverse Events Hemolysis	0 Participants
Adverse Events Right Heart Failure	1 Participants

SECONDARY outcome

Timeframe: Between 2 and 5 years post HM3 CE Mark study implant

Number of Participants with device malfunctions

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=25 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
Device Malfunctions	0 participants

SECONDARY outcome

Timeframe: Between 2 and 5 years post HM3 CE Mark study implant

Number of reoperations

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=25 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
Reoperations Major bleeding	1 events
Reoperations Major infection	6 events
Reoperations Neurologic dysfunction	4 events
Reoperations Other Reoperation	11 events

SECONDARY outcome

Timeframe: Between 2 and 5 years post HM3 CE Mark study implant

Number of rehospitalizations

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=25 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
Rehospitalizations Cardiac Arrhythmia	1 events
Rehospitalizations Infection	19 events
Rehospitalizations Bleeding	2 events
Rehospitalizations Neurological Event	2 events
Rehospitalizations Renal Dysfunction	1 events
Rehospitalizations Respiratory Insufficiency	0 events
Rehospitalizations Right Heart Failure	1 events
Rehospitalizations Other Adverse Event	13 events

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Ongoing HM3 CE Mark Study Patients n=25 Participants Ongoing HM3 CE Mark study (NCT02170363) patients that have consented to continue the long term follow-up data collection.
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 Interval 39.1 to 68.5
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 Interval 44.6 to 73.9

Adverse Events

Ongoing HM3 CE Mark Study Patients

Serious events: 13 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Ongoing HM3 CE Mark Study Patients n=25 participants at risk Ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.
Product Issues Pump Thrombosis	0.00% 0/25 • 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.
Vascular disorders Bleeding	12.0% 3/25 • 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.
Blood and lymphatic system disorders Hemolysis	0.00% 0/25 • 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.
Infections and infestations Infection	36.0% 9/25 • 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.
Cardiac disorders Right Heart Failure	4.0% 1/25 • 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.
Nervous system disorders Stroke, Hemorrhagic	12.0% 3/25 • 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.
Nervous system disorders Stroke, Ischemic	8.0% 2/25 • 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.
Cardiac disorders Cardiac Arrhythmia	4.0% 1/25 • 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.
Renal and urinary disorders Renal Dysfunction	4.0% 1/25 • 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.
Product Issues Outflow Graft Thrombosis	8.0% 2/25 • 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.
Nervous system disorders Other Neurological event	4.0% 1/25 • 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.
Product Issues Pump Malfunction	0.00% 0/25 • 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.
Nervous system disorders Psychiatric Episode	0.00% 0/25 • 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.
Hepatobiliary disorders Hepatic Dysfunction	0.00% 0/25 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	4.0% 1/25 • 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.
Injury, poisoning and procedural complications Wound Dehiscence	0.00% 0/25 • 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.
Vascular disorders Hypertension	0.00% 0/25 • 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.
Blood and lymphatic system disorders Pericardial Fluid Collection	0.00% 0/25 • 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.
Cardiac disorders Other Adverse Event	32.0% 8/25 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Poornima Sood

Abbott

Phone: +17818528334

Email: poornima.sood@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place