Advanced Heart Failure
Conditions
Keywords
HeartMate 3, Left ventricular assist device, ABT-CIP-10382
Brief summary
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.
Interventions
Advanced heart failure patients will be implanted with the HM3 LVAS
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement | Up to 6 months follow-up | Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (Modified Rankin Score \>3) or reoperation for pump replacement will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will be censored at that time in the analysis. |
| Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events | Up to 6 months follow-up | Cumulative occurrence of adverse events will be presented as percent of patients with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline | Baseline and 1 Month | The subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after the HM3 implant until the end of the surveillance period. EQ VAS scores range from 0 to 100, where 100 is the best possible health state. |
| Mean Change in Six-minute Walk Test From Baseline | Baseline and 1 Month post-implant | The 6-minute Walk test will be conducted at all follow-up visits until the end of the surveillance period. |
| Number of Participants With Device Malfunctions | Up to 6 months follow-up | All suspected HM3 device malfunctions will be reported. |
| Frequency of Rehospitalization and Reoperation | Up to 6 months follow-up | Frequency and reason will be reported for rehospitalization and reoperation. |
| Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline | Baseline and 1 Month post-implant | Subjects' NYHA Functional Status will be assessed at all scheduled follow-up visits until the end of the surveillance period. The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. |
Countries
Hong Kong, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) Patients will be implanted with the HM3 LVAS
HeartMate 3™ left ventricular assist system (HM3 LVAS): Advanced heart failure patients will be implanted with the HM3 LVAS | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Heart Transplant | 1 |
Baseline characteristics
| Characteristic | HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) |
|---|---|
| Age, Continuous | 47.3 years |
| Indication Bridge to Transplant | 3 Participants |
| Indication Destination Therapy | 0 Participants |
| Indication Other Indications | 0 Participants |
| INTERMACS 1 | 0 Participants |
| INTERMACS 2 | 1 Participants |
| INTERMACS 3 | 2 Participants |
| INTERMACS 4 | 0 Participants |
| INTERMACS 5 | 0 Participants |
| INTERMACS 6 | 0 Participants |
| INTERMACS 7 | 0 Participants |
| LVEF | 17.3 percentage of LVEF |
| NYHA Class I | 0 Participants |
| NYHA Class II | 0 Participants |
| NYHA Class IIIA | 0 Participants |
| NYHA Class IIIB | 0 Participants |
| NYHA Class IV | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement
Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (Modified Rankin Score \>3) or reoperation for pump replacement will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will be censored at that time in the analysis.
Time frame: Up to 6 months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement | 3 Participants |
Primary
Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events
Time frame: Up to 6 months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events | 2 Participants |
Secondary
Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline
Subjects' NYHA Functional Status will be assessed at all scheduled follow-up visits until the end of the surveillance period. The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time frame: Baseline and 1 Month post-implant
Population: Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline | Baseline | 4 Unit on a scale | Standard Deviation 0 |
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline | 1-Month follow-up | 2 Unit on a scale | Standard Deviation 1 |
Secondary
Frequency of Rehospitalization and Reoperation
Frequency and reason will be reported for rehospitalization and reoperation.
Time frame: Up to 6 months follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Frequency of Rehospitalization and Reoperation | Rehospitalizations | 1 number of events |
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Frequency of Rehospitalization and Reoperation | Reoperations | 2 number of events |
Secondary
Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline
The subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after the HM3 implant until the end of the surveillance period. EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: Baseline and 1 Month
Population: Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline | Baseline | 63.3 score on a scale | Standard Deviation 12.6 |
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline | 1 Month post-implant | 83.3 score on a scale | Standard Deviation 15.3 |
Secondary
Mean Change in Six-minute Walk Test From Baseline
The 6-minute Walk test will be conducted at all follow-up visits until the end of the surveillance period.
Time frame: Baseline and 1 Month post-implant
Population: Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Mean Change in Six-minute Walk Test From Baseline | Baseline | 175.3 meters | Standard Deviation 159 |
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Mean Change in Six-minute Walk Test From Baseline | 1 Month post-implant | 197.3 meters | Standard Deviation 248.2 |
Secondary
Number of Participants With Device Malfunctions
All suspected HM3 device malfunctions will be reported.
Time frame: Up to 6 months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) | Number of Participants With Device Malfunctions | 0 number of patients |