Hong Kong and Taiwan HM3 PMS

NCT04703855 | Terminated Results FDA Device

• 2 other identifiers: ABT-CIP-10382CRD 1022
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 3

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.

Conditions

Advanced Heart Failure

Keywords

HeartMate 3; Left ventricular assist device; ABT-CIP-10382

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Mean Change in Six-minute Walk Test From Baseline

  Baseline and 1 Month post-implant

• 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

• Frequency of Rehospitalization and Reoperation

  Up to 6 months follow-up

• Number of Participants With Device Malfunctions

  Up to 6 months follow-up

Study Arms (1)

HeartMate 3™ left ventricular assist system (HM3 LVAS)

EXPERIMENTAL

Patients will be implanted with the HM3 LVAS

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

Interventions

HeartMate 3™ left ventricular assist system (HM3 LVAS) DEVICE

Advanced heart failure patients will be implanted with the HM3 LVAS

HeartMate 3™ left ventricular assist system (HM3 LVAS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

University of Hong Kong

Hong Kong, Pokfulam, Hong Kong

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Limitations and Caveats

The trial has been prematurely ended. Three 3 subjects were enrolled of which 2 have reached their 3 months follow-up and 1 reached 6 months at the time of study interruption.

Results Point of Contact

• Title: Carlo Gazzola
• Organization: Abbott

carlo.gazzola@abbott.com

+3227746811

Study Officials

• Carlo Gazzola, B. Sc.

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: July 14, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: July 1, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); TW (2)