Heart Failure
Conditions
Brief summary
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
Detailed description
Patients who participated in prior trials will be approached for this PAS as follows: * Patients who are on continued HeartWare® System support, (original or exchange device) * Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up Patients who participated in prior trials who will not be approached to participate in this follow-up study include: • Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial). No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.
Interventions
DEVICEHeartWare® VAS
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient has participated in a prior HeartWare trial under IDE G070199. 2. The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial. 3. The patient has signed informed consent for participation in the study.
Exclusion criteria
1. The patient is unwilling or unable to comply with trial requirements. 2. The patient did not sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival on Device | Implant to 5 years | Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-hospitalizations | Enrollment into HW-PAS-03 to 5 years | A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study. |
| Number of Participants Experiencing Any Adverse Event Per Intermacs Definition | Enrollment into HW-PAS-03 to 5 years | Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device. |
| Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Change from baseline to 5 years | Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement. |
| Final Patient Status | Implant to 5 years | The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first. |
| Change in Functional Status Measured by New York Heart Association (NYHA) Class | Change from baseline to 5 years | Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III). |
| Change in Functional Status Measured by 6-minute Walk | Change from baseline to 5 years | Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement. |
| Health Status Change Measured by EuroQol EQ-5D (Version 5L) | Enrollment to 5 years | The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state). |
Countries
United States
Participant flow
Pre-assignment details
Of the 101 enrolled subjects, 17 subjects enrolled post-transplant and were no longer on the HVAD device at the time of enrollment, leaving 84 subjects who enrolled while still on the HVAD device.
Participants by arm
| Arm | Count |
|---|---|
| HeartWare® VAS Ventricular Assist Device (HeartWare® VAS)
HeartWare® VAS: The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | HeartWare® VAS |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 12.62 |
| Enrollment Characteristics On Device | 84 Participants |
| Enrollment Characteristics Post Transplant | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 37 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 59 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 34 / 101 |
| other Total, other adverse events | 10 / 84 |
| serious Total, serious adverse events | 62 / 84 |
Outcome results
Primary
Overall Survival on Device
Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.
Time frame: Implant to 5 years
Population: All enrolled subjects are included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeartWare® VAS | Overall Survival on Device | 52.9 Percent Probability of Survival |
Secondary
Change in Functional Status Measured by 6-minute Walk
Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement.
Time frame: Change from baseline to 5 years
Population: Participants who enrolled into the trial on device are included. Subjects also had to reach the Month 60 visit and complete the assessment or indicate Not Completed to be analyzed at both the baseline and Month 60 visits. If the subject did not complete the assessment, a value of 0 was imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HeartWare® VAS | Change in Functional Status Measured by 6-minute Walk | 106.6 Meters | Standard Deviation 184.05 |
Secondary
Change in Functional Status Measured by New York Heart Association (NYHA) Class
Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).
Time frame: Change from baseline to 5 years
Population: Participants who enrolled into the trial on device were included. Participants also had to reach the Month 60 visit and complete the assessment to be analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HeartWare® VAS | Change in Functional Status Measured by New York Heart Association (NYHA) Class | No Change in NYHA Class | 2 Participants |
| HeartWare® VAS | Change in Functional Status Measured by New York Heart Association (NYHA) Class | Improved 1 NYHA Class | 5 Participants |
| HeartWare® VAS | Change in Functional Status Measured by New York Heart Association (NYHA) Class | Improved 2 NYHA Classes | 7 Participants |
| HeartWare® VAS | Change in Functional Status Measured by New York Heart Association (NYHA) Class | Improved 3 NYHA Classes | 8 Participants |
Secondary
Final Patient Status
The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first.
Time frame: Implant to 5 years
Population: All enrolled subjects are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HeartWare® VAS | Final Patient Status | Alive on Original Device | 21 Participants |
| HeartWare® VAS | Final Patient Status | Alive Post Exchange | 5 Participants |
| HeartWare® VAS | Final Patient Status | Alive Post Explant for Transplant | 41 Participants |
| HeartWare® VAS | Final Patient Status | Alive Post Explant for Recovery | 0 Participants |
| HeartWare® VAS | Final Patient Status | Dead on Original Device | 22 Participants |
| HeartWare® VAS | Final Patient Status | Dead Post Exchange | 6 Participants |
| HeartWare® VAS | Final Patient Status | Dead Post Explant for Transplant | 6 Participants |
| HeartWare® VAS | Final Patient Status | Dead Post Explant for Recovery | 0 Participants |
Secondary
Health Status Change Measured by EuroQol EQ-5D (Version 5L)
The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state).
Time frame: Enrollment to 5 years
Population: Participants who enrolled into the trial on device are included. Participants also had to reach the Month 60 visit complete the assessment to be analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HeartWare® VAS | Health Status Change Measured by EuroQol EQ-5D (Version 5L) | 66.84 score on a scale | Standard Deviation 22.124 |
Secondary
Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.
Time frame: Change from baseline to 5 years
Population: Participants who enrolled into the trial on device are included. Participants also had to reach the Month 60 visit and complete both the baseline and Month 60 assessments to be analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HeartWare® VAS | Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 20.1 score on a scale | Standard Deviation 21.32 |
Secondary
Number of Participants Experiencing Any Adverse Event Per Intermacs Definition
Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device.
Time frame: Enrollment into HW-PAS-03 to 5 years
Population: Participants who enrolled into the trial on device are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HeartWare® VAS | Number of Participants Experiencing Any Adverse Event Per Intermacs Definition | 66 Participants |
Secondary
Re-hospitalizations
A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study.
Time frame: Enrollment into HW-PAS-03 to 5 years
Population: Participants who enrolled into the trial on device are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HeartWare® VAS | Re-hospitalizations | 3.9 Re-hospitalizations | Standard Deviation 3.8 |