Back to resultsHong Kong and Taiwan HM3 PMS
Primary Purpose
Advanced Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HeartMate 3™ left ventricular assist system (HM3 LVAS)
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Heart Failure focused on measuring HeartMate 3, Left ventricular assist device, ABT-CIP-10382
Eligibility Criteria
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
Sites / Locations
- University of Hong Kong
- National Taiwan University Hospital
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HeartMate 3™ left ventricular assist system (HM3 LVAS)
Arm Description
Patients will be implanted with the HM3 LVAS
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Full Information
NCT ID
NCT04703855
First Posted
January 8, 2021
Last Updated
December 1, 2022
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT04703855
Brief Title
Hong Kong and Taiwan HM3 PMS
Official Title
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment and regulatory status change
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Heart Failure
Keywords
HeartMate 3, Left ventricular assist device, ABT-CIP-10382
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HeartMate 3™ left ventricular assist system (HM3 LVAS)
Arm Type
Experimental
Arm Description
Patients will be implanted with the HM3 LVAS
Intervention Type
Device
Intervention Name(s)
HeartMate 3™ left ventricular assist system (HM3 LVAS)
Intervention Description
Advanced heart failure patients will be implanted with the HM3 LVAS
Primary Outcome Measure Information:
Title
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
Description
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
Throughout the study (approximately 24 months post implant)
Title
Primary Safety Endpoint: Number of cumulative occurrence of adverse events
Description
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events and events per patient year of support.
Time Frame
Throughout the study (approximately 24 months post implant)
Secondary Outcome Measure Information:
Title
Mean change in Six-minute Walk Test from baseline
Description
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.
Time Frame
At 1 month post implant
Title
Mean change in Six-minute Walk Test from baseline
Description
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.
Time Frame
At 3 months post implant
Title
Mean change in Six-minute Walk Test from baseline
Description
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.
Time Frame
At 6 months post implant
Title
Mean change in Six-minute Walk Test from baseline
Description
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.
Time Frame
At 12 months post implant
Title
Mean change in Six-minute Walk Test from baseline
Description
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.
Time Frame
At 24 months post implant
Title
Change proportion of New York Heart Association (NYHA) Functional Status from baseline
Description
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.
Time Frame
At 1 month post implant
Title
Change proportion of New York Heart Association (NYHA) Functional Status from baseline
Description
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.
Time Frame
At 3 months post implant
Title
Change proportion of New York Heart Association (NYHA) Functional Status from baseline
Description
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.
Time Frame
At 6 months post implant
Title
Change proportion of New York Heart Association (NYHA) Functional Status from baseline
Description
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.
Time Frame
At 12 months post implant
Title
Change proportion of New York Heart Association (NYHA) Functional Status from baseline
Description
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.
Time Frame
At 24 months post implant
Title
Mean change in EQ-5D-5L quality of life (QoL) from baseline
Description
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.
Time Frame
At 1 month post implant
Title
Mean change in EQ-5D-5L quality of life (QoL) from baseline
Description
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.
Time Frame
At 3 months post implant
Title
Mean change in EQ-5D-5L quality of life (QoL) from baseline
Description
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.
Time Frame
At 6 months post implant
Title
Mean change in EQ-5D-5L quality of life (QoL) from baseline
Description
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.
Time Frame
At 12 months post implant
Title
Mean change in EQ-5D-5L quality of life (QoL) from baseline
Description
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.
Time Frame
At 24 months post implant
Title
Frequency of Rehospitalization and Reoperation
Description
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.
Time Frame
Throughout the study (approximately 24 months post implant)
Title
Number of participants with Device Malfunctions
Description
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
Time Frame
Throughout the study (approximately 24 months post implant)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Gazzola, B. Sc.
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
State/Province
Pokfulam
Country
Hong Kong
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hong Kong and Taiwan HM3 PMS
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