Trial Outcomes & Findings for Hong Kong and Taiwan HM3 PMS (NCT NCT04703855)
NCT ID: NCT04703855
Last Updated: 2024-07-01
Results Overview
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.
TERMINATED
NA
3 participants
Up to 6 months follow-up
2024-07-01
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Heart Transplant
|
1
|
Baseline Characteristics
Hong Kong and Taiwan HM3 PMS
Baseline characteristics by cohort
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
Age, Continuous
|
47.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
NYHA
Class IV
|
3 Participants
n=5 Participants
|
|
NYHA
Class IIIB
|
0 Participants
n=5 Participants
|
|
NYHA
Class IIIA
|
0 Participants
n=5 Participants
|
|
NYHA
Class II
|
0 Participants
n=5 Participants
|
|
NYHA
Class I
|
0 Participants
n=5 Participants
|
|
INTERMACS
1
|
0 Participants
n=5 Participants
|
|
INTERMACS
2
|
1 Participants
n=5 Participants
|
|
INTERMACS
3
|
2 Participants
n=5 Participants
|
|
INTERMACS
4
|
0 Participants
n=5 Participants
|
|
INTERMACS
5
|
0 Participants
n=5 Participants
|
|
INTERMACS
6
|
0 Participants
n=5 Participants
|
|
INTERMACS
7
|
0 Participants
n=5 Participants
|
|
Indication
Bridge to Transplant
|
3 Participants
n=5 Participants
|
|
Indication
Destination Therapy
|
0 Participants
n=5 Participants
|
|
Indication
Other Indications
|
0 Participants
n=5 Participants
|
|
LVEF
|
17.3 percentage of LVEF
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months follow-upOverall 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.
Outcome measures
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
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 outcome
Timeframe: Up to 6 months follow-upCumulative occurrence of adverse events will be presented as percent of patients with adverse events
Outcome measures
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and 1 Month post-implantPopulation: Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end)
The 6-minute Walk test will be conducted at all follow-up visits until the end of the surveillance period.
Outcome measures
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
Mean Change in Six-minute Walk Test From Baseline
Baseline
|
175.3 meters
Standard Deviation 159.0
|
|
Mean Change in Six-minute Walk Test From Baseline
1 Month post-implant
|
197.3 meters
Standard Deviation 248.2
|
SECONDARY outcome
Timeframe: Baseline and 1 Month post-implantPopulation: Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end)
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.
Outcome measures
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline
Baseline
|
4 Unit on a scale
Standard Deviation 0
|
|
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 outcome
Timeframe: Baseline and 1 MonthPopulation: Three subjects performed the assessment at Baseline and 1-Month, while two performed at 3 Months and one at 6 months (study premature end)
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.
Outcome measures
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline
Baseline
|
63.3 score on a scale
Standard Deviation 12.6
|
|
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 outcome
Timeframe: Up to 6 months follow-upFrequency and reason will be reported for rehospitalization and reoperation.
Outcome measures
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
Frequency of Rehospitalization and Reoperation
Rehospitalizations
|
1 number of events
|
|
Frequency of Rehospitalization and Reoperation
Reoperations
|
2 number of events
|
SECONDARY outcome
Timeframe: Up to 6 months follow-upAll suspected HM3 device malfunctions will be reported.
Outcome measures
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 Participants
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
|
|---|---|
|
Number of Participants With Device Malfunctions
|
0 number of patients
|
Adverse Events
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
Serious adverse events
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 participants at risk
Patients implanted with the HeartMate 3™ left ventricular assist system (HM3 LVAS)
|
|---|---|
|
Infections and infestations
Infection
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline until study early termination. One subjects was followed until 6 months follow-up, while two reached 3 months visits
|
Other adverse events
| Measure |
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)
n=3 participants at risk
Patients implanted with the HeartMate 3™ left ventricular assist system (HM3 LVAS)
|
|---|---|
|
Cardiac disorders
Cardiac Arrhythmias
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from baseline until study early termination. One subjects was followed until 6 months follow-up, while two reached 3 months visits
|
|
Nervous system disorders
Neurological dysfunctions
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from baseline until study early termination. One subjects was followed until 6 months follow-up, while two reached 3 months visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60