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Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea

NCT04915924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2024-07-30

No results posted yet for this study

Summary

The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, 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 up to 300 patients, that meet the Health Insurance Review and Assessment (HIRA) guidelines for LVAD implantation, from up to 25 sites in South Korea. Subjects who will be implanted but not included in the PMS can be enrolled retrospectively after obtaining their informed consent. The surveillance period for this PMS is expected to be 4 years from the time of HM3 approval in Korea, concluding on June 2, 2024.

Conditions

  • Advanced Heart Failure

Interventions

DEVICE

HeartMate 3™ left ventricular assist system (HM3 LVAS)

Advanced heart failure patients will be implanted with the HM3 LVAS

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Carlo Gazzola · Abbott

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2024-06-02
Completion
2024-06-02
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04915924 on ClinicalTrials.gov