Hong Kong and Taiwan HM3 PMS

Not Applicable

Terminated

Conditions: Advanced Heart Failure

Interventions: Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)

Registration Number: NCT04703855

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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

None

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HeartMate 3™ left ventricular assist system (HM3 LVAS)	HeartMate 3™ left ventricular assist system (HM3 LVAS)	Patients will be implanted with the HM3 LVAS

Primary Outcome Measures

Name	Time	Method
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	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	Up to 6 months follow-up	Cumulative occurrence of adverse events will be presented as percent of patients with adverse events

Secondary Outcome Measures

Name	Time	Method
Mean Change in Six-minute Walk Test From Baseline	Baseline and 1 Month post-implant	The 6-minute Walk test will be conducted at all follow-up visits until the end of the surveillance period.
Frequency of Rehospitalization and Reoperation	Up to 6 months follow-up	Frequency and reason will be reported for rehospitalization and reoperation.
Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline	Baseline and 1 Month post-implant	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.
Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline	Baseline and 1 Month	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.
Number of Participants With Device Malfunctions	Up to 6 months follow-up	All suspected HM3 device malfunctions will be reported.

Trial Locations

Locations (3): National Taiwan University Hospital
🇨🇳
Taipei City, Taiwan
Tri-Service General Hospital
🇨🇳
Taipei City, Taiwan
University of Hong Kong
🇭🇰
Hong Kong, Pokfulam, Hong Kong