Hong Kong and Taiwan HM3 PMS is a prospective, single arm, 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 approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Advanced heart failure patients will be implanted with the HM3 LVAS
University of Hong Kong
Hong Kong, Pokfulam, Hong Kong
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement
Overall survival to transplant, myocardial recovery or on device support free of debilitating 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: Up to 6 months follow-up
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
Time frame: Up to 6 months follow-up
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.
Time frame: Baseline and 1 Month post-implant
Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline
Subjects' NYHA Functional Status will be assessed at all scheduled follow-up visits until the end of the surveillance period. The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
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Time frame: Baseline and 1 Month post-implant
Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline
The subject's quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after the HM3 implant until the end of the surveillance period. EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: Baseline and 1 Month
Frequency of Rehospitalization and Reoperation
Frequency and reason will be reported for rehospitalization and reoperation.
Time frame: Up to 6 months follow-up
Number of Participants With Device Malfunctions
All suspected HM3 device malfunctions will be reported.
Time frame: Up to 6 months follow-up