Advanced Heart FailureNCT04915924
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
A study testing HeartMate 3™ left ventricular assist system (HM3 LVAS) in people with Advanced Heart Failure, run by Abbott Medical Devices at 22 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Heart Failure
- What is being tested?
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 22 sitesSouth Korea
- Study dates
- 30 Oct 2020to 2 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- This post market surveillance does not have specific exclusion criteria
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
South Korea22 sites
Korea University Ansan Hospital
Ansan
Sejong Hospital
Bucheon-si
Pusan National University Hospital
Busan
Gyeongsang National University Changwon Hospital
Changwon
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon
Chonnam National University Hospital (CNUH)
Gwangju, Gwangju, 58128
Hallym University Dongtan Sacred Heart Hospital
Hwaseong
Hallym University Sacred Heart Hospital
Hwaseong
Seoul National University Hospital
Ihwa-dong
Incheon Sejong Hospital
Incheon, Nam-gu, 726
Gachon University Gil Hospital
Incheon
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul St. Mary's Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
St. Mary's Hospital, The Catholic University of Eunpyeong
Seoul
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: 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.
- Conditions
- Advanced Heart Failure
- Being tested
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Keywords
- HeartMate 3, ABT-CIP-10344, Left ventricular assist device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMate 3™ left ventricular assist system (HM3 LVAS)Device
Advanced heart failure patients will be implanted with the HM3 LVAS
| Study group | Role | What they receive |
|---|---|---|
| HeartMate 3™ left ventricular assist system (HM3 LVAS) | Experimental | Patients will be implanted with the HM3 LVAS Receives: Device: HeartMate 3™ left ventricular assist system (HM3 LVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment until the study conclusion date (up to 43 months, 3 days)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment until the study conclusion date (up to 43 months, 3 days)
Frequency of Reoperation
Number of reoperation events inclusive of heart transplantations.
Measured: 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.
Measured: From enrollment until the study conclusion date (up to 43 months, 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start30 Oct 2020
- Primary completion2 Jun 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Gazzola, Principal investigator, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915924
- Sponsor's protocol ID
- ABT-CIP-10344
- Status last verified
- Feb 2026
- First submitted
- 1 Jun 2021
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No