Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea

Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (Korea HM3 PMS)

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Heart Failure
• Intervention / Treatment: Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evonne Poon; Phone Number: +65 69148433; Email: evonnesueyin.poon@abbott.com
• Study Contact Backup: Name: Carlo Gazzola; Phone Number: +32499544066; Email: carlo.gazzola@abbott.com

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Recruiting
    • Korea University Ansan Hospital
    • Principal Investigator: Yonghyun Kim
  • Bucheon, Korea, Republic of
    • Recruiting
    • Sejong Hospital
    • Principal Investigator: Heemoon Lee
  • Busan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
    • Principal Investigator: Seung-Hwan Song
  • Changwon, Korea, Republic of
    • Not yet recruiting
    • Gyeongsang National University Changwon Hospital
    • Principal Investigator: Jongwoo Kim
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Woo Sung Jang
  • Daegu, Korea, Republic of
    • Active, not recruiting
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of
    • Not yet recruiting
    • Chungnam National University Hospital
    • Principal Investigator: Sunah Jin
  • Gwangju, Korea, Republic of, 58128
    • Recruiting
    • Chonnam National University Hospital (CNUH)
    • Principal Investigator: In-Seok Jeong
  • Hwaseong, Korea, Republic of
    • Not yet recruiting
    • Hallym University Dongtan Sacred Heart Hospital
    • Principal Investigator: Sunki Lee
  • Hwaseong, Korea, Republic of
    • Not yet recruiting
    • Hallym University Sacred Heart Hospital
    • Principal Investigator: Hyungsoo Kim
  • Ihwa-dong, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Hyunjai Cho
  • Incheon, Korea, Republic of
    • Not yet recruiting
    • Gachon University Gil Hospital
    • Principal Investigator: Wookjin Jung
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • Seoul National University Bundang Hospital
    • Principal Investigator: Jun Sung Kim
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Principal Investigator: MinSeok Kim
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Yang Hyun Cho
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul ST. Mary's Hospital
    • Principal Investigator: Jong Chan Yoon
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Principal Investigator: Jaeseung Jung
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital, Yonsei University Health System
    • Principal Investigator: Young Nam Yoon
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Gangnam Severance Hospital
    • Principal Investigator: Eui Young Choi
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • St. Mary's Hospital, The Catholic University of Eunpyeong
    • Principal Investigator: SukMin Seo
  • Yangsan, Korea, Republic of
    • Recruiting
    • Pusan National University Yangsan Hospital
    • Principal Investigator: Soo Yong Lee
  • Nam-gu
    • Incheon, Nam-gu, Korea, Republic of, 726
      • Recruiting
      • Incheon Sejong Hospital
      • Principal Investigator: Kyung-Hee Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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 (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.	Throughout the study (approximately 4 years)
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 4 years)

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. 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.	Through study completion, an average of 4 years
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.	Through study completion, an average of 4 years
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.	Through study completion, an average of 4 years
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 4 years)
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	Throughout the study (approximately 4 years)
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.	Throughout the study (approximately 4 years)

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Carlo Gazzola, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Estimated): June 2, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HeartMate 3; Left ventricular assist device; ABT-CIP-10344
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ABT-CIP-10344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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