Hong Kong and Taiwan HM3 PMS

Advanced Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04703855
• Other study ID #: ABT-CIP-10382
• Secondary ID: CRD 1022
• Status: Terminated
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Heart Failure
• Heart Failure

Intervention

Device:
• HeartMate 3™ left ventricular assist system (HM3 LVAS)
Advanced heart failure patients will be implanted with the HM3 LVAS

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong	Pokfulam
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Tri-Service General Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Hong Kong,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Throughout the study (approximately 24 months post implant)
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 and events per patient year of support.	Throughout the study (approximately 24 months post implant)
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. 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
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. 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
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. 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
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. 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
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. 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
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. 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
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. 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
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. 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
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. 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
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. 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)