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

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Ansan, South Korea
    • Korea University Ansan Hospital
  • Bucheon-si, South Korea
    • Sejong Hospital
  • Busan, South Korea
    • Pusan National University Hospital
  • Changwon, South Korea
    • Gyeongsang National University Changwon Hospital
  • Daegu, South Korea
    • Keimyung University Dongsan Medical Center
  • Daegu, South Korea
    • Kyungpook National University Hospital
  • Daejeon, South Korea
    • Chungnam National University Hospital
  • Hwaseong, South Korea
    • Hallym University Dongtan Sacred Heart Hospital
  • Hwaseong, South Korea
    • Hallym University Sacred Heart Hospital
  • Ihwa-dong, South Korea
    • Seoul National University Hospital
  • Incheon, South Korea
    • Gachon University Gil Hospital
  • Seongnam-si, South Korea
    • Seoul National University Bundang Hospital
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • Korea University Anam Hospital
  • Seoul, South Korea
    • Samsung Medical Center
  • Seoul, South Korea
    • Gangnam Severance Hospital
  • Seoul, South Korea
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea
    • Seoul St. Mary'S Hospital
  • Seoul, South Korea
    • St. Mary's Hospital, The Catholic University of Eunpyeong
  • Yangsan, South Korea
    • Pusan National University Yangsan Hospital
  • Gwangju
    • Gwangju, Gwangju, South Korea, 58128
      • Chonnam National University Hospital (CNUH)
  • Nam-gu
    • Incheon, Nam-gu, South Korea, 726
      • Incheon Sejong Hospital

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

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: Kaplan-Meier Success Rate of 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. 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 not be considered to have experienced a primary endpoint event.	From enrollment to 36 months
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events	Cumulative occurrence of adverse events will be presented as percent of patients with adverse events.	From enrollment until the study conclusion date (up to 43 months, 3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute Walk Test Distance	The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.	Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant
New York Heart Association (NYHA) Functional Status	Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.	Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant
EQ-5D-5L Quality-of-Life Visual Analog Scale	Subject's quality-of-life (QoL) 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 EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life. The overall mean and standard deviation of the Visual Analog Scale (VAS) will be presented for all follow-up visits. The VAS is not available for all participants at all follow up timepoints.	Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months Post-Implant
Frequency of Rehospitalization	Frequency of rehospitalization events inclusive of rehospitalization for heart transplantation.	From enrollment until the study conclusion date (up to 43 months, 3 days)
Frequency of Reoperation	Number of reoperation events inclusive of heart transplantations.	From enrollment until the study conclusion date (up to 43 months, 3 days)
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.	From enrollment until the study conclusion date (up to 43 months, 3 days)

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 (Actual): June 2, 2024
• Study Completion (Actual): June 2, 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): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: February 1, 2026

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