Hong Kong and Taiwan HM3 PMS

Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan

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 Overview

• Status: Terminated
• Conditions: Advanced Heart Failure
• Intervention / Treatment: Device: HeartMate 3™ left ventricular assist system (HM3 LVAS)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Pokfulam
    • Hong Kong, Pokfulam, Hong Kong
      • University of Hong Kong
• Taiwan
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei City, Taiwan, 114
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HeartMate 3™ left ventricular assist system (HM3 LVAS); Patients will be implanted with the HM3 LVAS	Device: HeartMate 3™ left ventricular assist system (HM3 LVAS); Advanced heart failure patients will be implanted with the HM3 LVAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Up to 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and 1 Month
Frequency of Rehospitalization and Reoperation	Frequency and reason will be reported for rehospitalization and reoperation.	Up to 6 months follow-up
Number of Participants With Device Malfunctions	All suspected HM3 device malfunctions will be reported.	Up to 6 months follow-up

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Carlo Gazzola, B. Sc., Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: HeartMate 3; Left ventricular assist device; ABT-CIP-10382
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ABT-CIP-10382; CRD 1022 (Other Identifier: Other Study ID Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes