Back to resultsPost Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
Primary Purpose
Advanced Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
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, ABT-CIP-10344, Left ventricular assist device
Eligibility Criteria
Inclusion Criteria: All patients approved for HM3 implantation in Korea as per HIRA guidelines will be eligible to be enrolled in the PMS. Only the patients who provide written informed consent will be included in the study. If a subject has had an outcome after the HM3 implantation but prior to providing informed consent, no consent will be obtained, and a limited anonymized data will be collected.
Exclusion Criteria: None
Sites / Locations
- Incheon Sejong HospitalRecruiting
- Korea University Ansan HospitalRecruiting
- Sejong HospitalRecruiting
- Pusan National University HospitalRecruiting
- Gyeongsang National University Changwon Hospital
- Keimyung University Dongsan Medical CenterRecruiting
- Kyungpook National University Hospital
- Chungnam National University Hospital
- Chonnam National University Hospital (CNUH)Recruiting
- Hallym University Dongtan Sacred Heart Hospital
- Hallym University Sacred Heart Hospital
- Seoul National University HospitalRecruiting
- Gachon University Gil Hospital
- Seoul National University Bundang HospitalRecruiting
- Asan Medical CenterRecruiting
- Gangnam Severance Hospital
- Korea University Anam HospitalRecruiting
- Samsung Medical CenterRecruiting
- Seoul St. Mary's HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- St. Mary's Hospital, The Catholic University of Eunpyeong
- Pusan National University Yangsan HospitalRecruiting
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 (60 days post-stroke Modified Rankin Score >3) or reoperation for pump replacement
Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (60 days post-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. Distance walked at each visit will be compared to baseline using Wilcoxon signed-rank test. To assess the overall changes, repeated measure analysis will be performed using all data collected from baseline to 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 in proportion of New York Heart Association (NYHA) Functional Status from baseline
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 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.
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. Device malfunctions will be collected under the general category of Device Deficiencies. Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate labeling. This includes the failure of the device to meet its performance specifications or otherwise perform as intended. 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
Incidence of adverse events including, but not limited to, neurological dysfunction, bleeding, infections and device thrombosis.
Incidence of adverse events will be assessed including, but not limited to, neurological dysfunction, bleeding, infections and device thrombosis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04915924
Brief Title
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
Official Title
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (Korea HM3 PMS)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
June 2, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
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
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, 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 up to 300 patients, that meet the Health Insurance Review and Assessment (HIRA) guidelines for LVAD implantation, from up to 25 sites in South Korea. Subjects who will be implanted but not included in the PMS can be enrolled retrospectively after obtaining their informed consent. The surveillance period for this PMS is expected to be 4 years from the time of HM3 approval in Korea, concluding on June 2, 2024.
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, ABT-CIP-10344, Left ventricular assist device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
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 (60 days post-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 (60 days post-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 4 years)
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 4 years)
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. Distance walked at each visit will be compared to baseline using Wilcoxon signed-rank test. To assess the overall changes, repeated measure analysis will be performed using all data collected from baseline to 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
Through study completion, an average of 4 years
Title
Change in proportion of New York Heart Association (NYHA) Functional Status from baseline
Description
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 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
Through study completion, an average of 4 years
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
Through study completion, an average of 4 years
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 4 years)
Title
Number of participants with Device Malfunctions
Description
All suspected HM3 device malfunctions will be reported. Device malfunctions will be collected under the general category of Device Deficiencies. Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate labeling. This includes the failure of the device to meet its performance specifications or otherwise perform as intended. 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 4 years)
Title
Incidence of adverse events including, but not limited to, neurological dysfunction, bleeding, infections and device thrombosis.
Description
Incidence of adverse events will be assessed including, but not limited to, neurological dysfunction, bleeding, infections and device thrombosis.
Time Frame
Throughout the study (approximately 4 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
General Inclusion Criteria: All patients approved for HM3 implantation in Korea as per HIRA guidelines will be eligible to be enrolled in the PMS. Only the patients who provide written informed consent will be included in the study. If a subject has had an outcome after the HM3 implantation but prior to providing informed consent, no consent will be obtained, and a limited anonymized data will be collected.
Exclusion Criteria
General Exclusion Criteria: This post market surveillance does not have specific exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evonne Poon
Phone
+65 69148433
Email
evonnesueyin.poon@abbott.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Gazzola
Phone
+32499544066
Email
carlo.gazzola@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Gazzola
Organizational Affiliation
Abbott
Official's Role
Principal Investigator
Facility Information:
Facility Name
Incheon Sejong Hospital
City
Incheon
State/Province
Nam-gu
ZIP/Postal Code
726
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung-Hee Kim
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghyun Kim
Facility Name
Sejong Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heemoon Lee
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Hwan Song
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jongwoo Kim
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Sung Jang
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunah Jin
Facility Name
Chonnam National University Hospital (CNUH)
City
Gwangju
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-Seok Jeong
Facility Name
Hallym University Dongtan Sacred Heart Hospital
City
Hwaseong
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunki Lee
Facility Name
Hallym University Sacred Heart Hospital
City
Hwaseong
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyungsoo Kim
Facility Name
Seoul National University Hospital
City
Ihwa-dong
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyunjai Cho
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wookjin Jung
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Sung Kim
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MinSeok Kim
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eui Young Choi
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaeseung Jung
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Hyun Cho
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Chan Yoon
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Nam Yoon
Facility Name
St. Mary's Hospital, The Catholic University of Eunpyeong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukmin Seo
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Yong Lee
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
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