Hong Kong and Taiwan HM3 PMS

Study Overview
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Brief Summary
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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.

Official Title
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Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan

Conditions
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Advanced Heart Failure

Intervention / Treatment
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* Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartMate 3™ left ventricular assist system (HM3 LVAS)<br>Patients will be implanted with the HM3 LVAS | Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)<br>* Advanced heart failure patients will be implanted with the HM3 LVAS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Throughout the study (approximately 24 months post implant) | 
| 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 and events per patient year of support. | Throughout the study (approximately 24 months post implant) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in walking distance between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in walking distance over time. | At 1 month post implant | 
| 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. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in walking distance between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in walking distance over time. | At 3 months post implant | 
| 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. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in walking distance between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in walking distance over time. | At 6 months post implant | 
| 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. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in walking distance between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in walking distance over time. | At 12 months post implant | 
| 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. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in walking distance between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in walking distance over time. | At 24 months post implant | 
| 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. Percent of subjects in each NYHA class will be presented for all follow-up visits. For comparison, patients will be grouped into NYHA Class I/II (No limitation and Slight limitation of physical activity) vs. NYHA Class III/IV (Marked limitation and Inability to carry out physical activities). McNemar's test will then be used to assess if there is an increase in proportion of Class I and II subjects at each visit comparing to the baseline. | At 1 month post implant | 
| 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. Percent of subjects in each NYHA class will be presented for all follow-up visits. For comparison, patients will be grouped into NYHA Class I/II (No limitation and Slight limitation of physical activity) vs. NYHA Class III/IV (Marked limitation and Inability to carry out physical activities). McNemar's test will then be used to assess if there is an increase in proportion of Class I and II subjects at each visit comparing to the baseline. | At 3 months post implant | 
| 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. Percent of subjects in each NYHA class will be presented for all follow-up visits. For comparison, patients will be grouped into NYHA Class I/II (No limitation and Slight limitation of physical activity) vs. NYHA Class III/IV (Marked limitation and Inability to carry out physical activities). McNemar's test will then be used to assess if there is an increase in proportion of Class I and II subjects at each visit comparing to the baseline. | At 6 months post implant | 
| 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. Percent of subjects in each NYHA class will be presented for all follow-up visits. For comparison, patients will be grouped into NYHA Class I/II (No limitation and Slight limitation of physical activity) vs. NYHA Class III/IV (Marked limitation and Inability to carry out physical activities). McNemar's test will then be used to assess if there is an increase in proportion of Class I and II subjects at each visit comparing to the baseline. | At 12 months post implant | 
| 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. Percent of subjects in each NYHA class will be presented for all follow-up visits. For comparison, patients will be grouped into NYHA Class I/II (No limitation and Slight limitation of physical activity) vs. NYHA Class III/IV (Marked limitation and Inability to carry out physical activities). McNemar's test will then be used to assess if there is an increase in proportion of Class I and II subjects at each visit comparing to the baseline. | At 24 months post implant | 
| Mean change in EQ-5D-5L quality of life (QoL) from baseline | Subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after HM3 implant until the end of surveillance period. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in QoL Score between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in QoL over time. | At 1 month post implant | 
| Mean change in EQ-5D-5L quality of life (QoL) from baseline | Subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after HM3 implant until the end of surveillance period. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in QoL Score between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in QoL over time. | At 3 months post implant | 
| Mean change in EQ-5D-5L quality of life (QoL) from baseline | Subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after HM3 implant until the end of surveillance period. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in QoL Score between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in QoL over time. | At 6 months post implant | 
| Mean change in EQ-5D-5L quality of life (QoL) from baseline | Subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after HM3 implant until the end of surveillance period. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in QoL Score between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in QoL over time. | At 12 months post implant | 
| Mean change in EQ-5D-5L quality of life (QoL) from baseline | Subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after HM3 implant until the end of surveillance period. The overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in QoL Score between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in QoL over time. | At 24 months post implant | 
| Frequency of Rehospitalization and Reoperation | Frequency and reason will be reported for rehospitalization and reoperation. Freedom from rehospitalization and reoperation will be assessed using the Kaplan-Meier product-limit method. | Throughout the study (approximately 24 months post implant) | 
| Number of participants with Device Malfunctions | All suspected HM3 device malfunctions will be reported. Data on device malfunctions will be analyzed for the following: The component of the device involved Days to the malfunction Action taken in response to the malfunction Reoperations due to malfunction Death due to malfunction | Throughout the study (approximately 24 months post implant) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeartMate 3, Left ventricular assist device, ABT-CIP-10382