Trial Outcomes & Findings for A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage) (NCT NCT01831544)
NCT ID: NCT01831544
Last Updated: 2025-09-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Six month
Results posted on
2025-09-23
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Still on original MVAD device
|
2
|
Baseline Characteristics
A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)
Baseline characteristics by cohort
| Measure |
MVAD® Pump
n=11 Participants
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
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 14.53 • n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=93 Participants
|
|
Height
|
177.3 centimeters
STANDARD_DEVIATION 6.41 • n=93 Participants
|
|
Weight
|
73.5 kilograms
STANDARD_DEVIATION 14.36 • n=93 Participants
|
|
Blood Pressure
Systolic
|
101 mmHg
STANDARD_DEVIATION 15.58 • n=93 Participants
|
|
Blood Pressure
Diastolic
|
65.9 mmHg
STANDARD_DEVIATION 10.10 • n=93 Participants
|
|
Intermacs Patient Profile
1 - Critical cardiogenic shock
|
0 participants
n=93 Participants
|
|
Intermacs Patient Profile
2 - Progressive decline
|
0 participants
n=93 Participants
|
|
Intermacs Patient Profile
3 - Inotrope dependent
|
6 participants
n=93 Participants
|
|
Intermacs Patient Profile
4 - Resting symptoms
|
5 participants
n=93 Participants
|
|
Intermacs Patient Profile
5 - Exertion intolerant
|
0 participants
n=93 Participants
|
|
Intermacs Patient Profile
6 - Exertion limited
|
0 participants
n=93 Participants
|
|
Intermacs Patient Profile
7 - Advanced NYHA III
|
0 participants
n=93 Participants
|
|
Body Mass Index
|
23.2 kg/m^2
STANDARD_DEVIATION 3.41 • n=93 Participants
|
|
Body Surface Area
|
1.9 m^2
STANDARD_DEVIATION 0.21 • n=93 Participants
|
PRIMARY outcome
Timeframe: Six monthPrimary 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.
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Survival
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Two yearsSurvival 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.
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Survival
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System
Survival: Number of participants who died by six months and two years
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Survival: Number of Participants Who Died by Six Months and Two Years
Subjects who died by 6 months, cumulative
|
1 Participants
|
—
|
—
|
|
Survival: Number of Participants Who Died by Six Months and Two Years
Subjects who died by 2 years, cumulative
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System.
Incidence of major bleeding, per INTERMACS definition
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Incidence of Major Bleeding
Subjects who had an incidence of major bleeding by 6 months, cumulative
|
5 Participants
|
—
|
—
|
|
Incidence of Major Bleeding
Subjects who had an incidence of major bleeding by 2 years, cumulative
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System
Incidence of all device failures and device malfunctions per INTERMACS definition
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Incidence of All Device Failures and Device Malfunctions
Subjects with Device Malfunction by 6 months, cumulative
|
5 Participants
|
—
|
—
|
|
Incidence of All Device Failures and Device Malfunctions
Subjects with Device Malfunction by 2 years, cumulative
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System.
Incidence of major infection, per INTERMACS definition
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Incidence of Major Infection
Subjects with Major Infection by 6 months, cumulative
|
3 Participants
|
—
|
—
|
|
Incidence of Major Infection
Subjects with Major Infection by 2 years, cumulative
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System.
Incidence of neurological dysfunction per INTERMACS definition
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Incidence of Neurological Dysfunction
Subjects with Neurological Dysfunction by 6 months, cumulative
|
0 Participants
|
—
|
—
|
|
Incidence of Neurological Dysfunction
Subjects with Neurological Dysfunction by 2 years, cumulative
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six month and 24 month visitPopulation: No data displayed because Outcome Measure has zero total participants analyzed
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.
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
EQ5D Baseline
|
0.63 Score
Standard Deviation 0.29
|
—
|
—
|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
EQ5D 6 Months
|
0.67 Score
Standard Deviation 0.34
|
—
|
—
|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
EQ5D 6 Months vs baseline
|
0.13 Score
Standard Deviation 0.47
|
—
|
—
|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
EQ5D at 24 Months
|
0.94 Score
Standard Deviation 0.11
|
—
|
—
|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
EQ5D 24 Months vs baseline
|
0.21 Score
Standard Deviation 0.31
|
—
|
—
|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
KCCQ Overall Score Baseline
|
47.86 Score
Standard Deviation 21.79
|
—
|
—
|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
KCCQ Overall Score 6 Months
|
72.63 Score
Standard Deviation 16.10
|
—
|
—
|
|
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
|
—
|
—
|
|
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
KCCQ Overall Score 24 Months
|
81.94 Score
Standard Deviation 11.37
|
—
|
—
|
|
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 outcome
Timeframe: 6 month and 24 month visitPopulation: Subjects with implant attempt
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
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Functional Status Change, as Measured 6-minute Walk
Baseline
|
257.83 Distance in meters
Standard Deviation 93.7
|
—
|
—
|
|
Functional Status Change, as Measured 6-minute Walk
6 month visit
|
445.4 Distance in meters
Standard Deviation 71.71
|
—
|
—
|
|
Functional Status Change, as Measured 6-minute Walk
Change between 6 month visit and baseline
|
213 Distance in meters
Standard Deviation 81.97
|
—
|
—
|
|
Functional Status Change, as Measured 6-minute Walk
2 year visit
|
402 Distance in meters
Standard Deviation 74.95
|
—
|
—
|
|
Functional Status Change, as Measured 6-minute Walk
Change between 2 year visit and baseline
|
313 Distance in meters
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System.
Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Frequency and Rates of Adverse Events(AEs)
Subjects with First Adverse Event by 6 months, cumulative.
|
11 Participants
|
—
|
—
|
|
Frequency and Rates of Adverse Events(AEs)
Subjects with first Adverse Event by 2 years, cumulative.
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post operationPopulation: Subjects who underwent an MVAD implant attempt
Length of Initial hospital stay (days) from procedure start to discharge
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Length of Initial Hospital Stay (Days)
|
40.2 Days
Standard Deviation 15.56
|
—
|
—
|
SECONDARY outcome
Timeframe: On or before 6 months follow-up and 24 month follow-upPopulation: Subjects with an implant attempt
The length of Re-Hospitalization, excluding planned procedures, stay in days.
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Re-Hospitalizations
Length of Hospital Stay up to 6 month visit
|
34.82 Days
Standard Deviation 110.22
|
—
|
—
|
|
Re-Hospitalizations
Length of Hospital Stay Through 2 years
|
69.91 Days
Standard Deviation 113.66
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System.
Transplantations of subjects enrolled in study and implanted with MVAD System
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Transplantations
Subjects with transplant by 2 years, cumulative
|
3 Participants
|
—
|
—
|
|
Transplantations
Subjects with transplant by 6 months, cumulative
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Six months and two yearsPopulation: The number of subjects enrolled in the study and implanted with MVAD System.
Explants (i.e. death, transplant, recovery, device exchange) of MVAD in subjects enrolled in study and implanted with MVAD System
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Explants
Subjects with Explants by 6 months, cumulative
|
1 Participants
|
—
|
—
|
|
Explants
Subjects with Explants by 2 years, cumulative
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 month and 24 month visitPopulation: Subjects implanted with MVAD
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
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
n=7 Participants
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
n=3 Participants
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
New York Heart Association (NYHA) Functional Classification Score
Class I
|
0 Participants
|
3 Participants
|
3 Participants
|
|
New York Heart Association (NYHA) Functional Classification Score
Class II
|
0 Participants
|
4 Participants
|
0 Participants
|
|
New York Heart Association (NYHA) Functional Classification Score
Class III
|
6 Participants
|
0 Participants
|
0 Participants
|
|
New York Heart Association (NYHA) Functional Classification Score
Class IV
|
5 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: ImplantPopulation: Subjects who underwent an MVAD implant attempt
Length of operative time (hours)
Outcome measures
| Measure |
MVAD® Pump
n=11 Participants
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
|
MVAD Pump 6 Months
Subjects who underwent an implant attempt and had 6 month visit
|
MVAD Pump at 24 Months
Subjects with MVAD pump implant attempt and 24 month visit
|
|---|---|---|---|
|
Length of Operative Time (Hours)
|
2.78 Hours
Standard Deviation 0.53
|
—
|
—
|
Adverse Events
MVAD® Pump
Serious events: 7 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MVAD® Pump
n=11 participants at risk
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
|
|---|---|
|
Cardiac disorders
Pericardial Fluid Collection
|
18.2%
2/11 • Number of events 2 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Renal and urinary disorders
Renal Dysfunction
|
18.2%
2/11 • Number of events 2 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
9.1%
1/11 • Number of events 1 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
General disorders
Other
|
18.2%
2/11 • Number of events 11 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Vascular disorders
Arterial Non-CNS Thromboembolism
|
9.1%
1/11 • Number of events 1 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
27.3%
3/11 • Number of events 4 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Product Issues
Device Malfunction/Failure
|
27.3%
3/11 • Number of events 7 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Blood and lymphatic system disorders
Hemolysis
|
36.4%
4/11 • Number of events 4 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
9.1%
1/11 • Number of events 1 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Blood and lymphatic system disorders
Major Bleeding
|
63.6%
7/11 • Number of events 13 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
|
Infections and infestations
Major Infection
|
27.3%
3/11 • Number of events 4 • Through study completion: an average of 20.8 months but up to 2 years post implant.
|
Other adverse events
| Measure |
MVAD® Pump
n=11 participants at risk
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
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Cardiac disorders
Cardiac Arrhythmias
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9.1%
1/11 • Number of events 1 • Through study completion: an average of 20.8 months but up to 2 years post implant.
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Product Issues
Device malfunction/failure
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27.3%
3/11 • Number of events 3 • Through study completion: an average of 20.8 months but up to 2 years post implant.
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Infections and infestations
Major Infection
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18.2%
2/11 • Number of events 3 • Through study completion: an average of 20.8 months but up to 2 years post implant.
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General disorders
Other
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63.6%
7/11 • Number of events 27 • Through study completion: an average of 20.8 months but up to 2 years post implant.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60