Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Heart Failure
- Sponsor
- Abbott Medical Devices
- Enrollment
- 3
- Locations
- 3
- Primary Endpoint
- 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
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: Up to 6 months follow-up
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.
Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events
Time Frame: Up to 6 months follow-up
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events
Secondary Outcomes
- Mean Change in Six-minute Walk Test From Baseline(Baseline and 1 Month post-implant)
- Frequency of Rehospitalization and Reoperation(Up to 6 months follow-up)
- Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline(Baseline and 1 Month post-implant)
- Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline(Baseline and 1 Month)
- Number of Participants With Device Malfunctions(Up to 6 months follow-up)