Clinical trial NCT04915924: 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
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Heart Failure
Keywords: HeartMate 3
ABT-CIP-10344
Left ventricular assist device
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-06-07
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Throughout the study (approximately 4 years)
measure: Primary Safety Endpoint: Number of cumulative occurrence of adverse events
timeFrame: Throughout the study (approximately 4 years)
Secondary outcomes:
measure: Mean change in Six-minute Walk Test from baseline
timeFrame: Through study completion, an average of 4 years
measure: Change in proportion of New York Heart Association (NYHA) Functional Status from baseline
timeFrame: Through study completion, an average of 4 years
measure: Mean change in EQ-5D-5L quality of life (QoL) from baseline
timeFrame: Through study completion, an average of 4 years
measure: Frequency of Rehospitalization and Reoperation
timeFrame: Throughout the study (approximately 4 years)
measure: Number of participants with Device Malfunctions
timeFrame: Throughout the study (approximately 4 years)
measure: Incidence of adverse events including, but not limited to, neurological dysfunction, bleeding, infections and device thrombosis.
timeFrame: Throughout the study (approximately 4 years)
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon Sejong Hospital
state: Nam-gu
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Bucheon
country: Korea, Republic of
facility: Sejong Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital (CNUH)
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Ihwa-dong
country: Korea, Republic of
facility: Seoul National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital, The Catholic University of Eunpyeong
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Abbott
name: Carlo Gazzola
role: PRINCIPAL_INVESTIGATOR
References: