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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2024-06-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HeartMate 3™ left ventricular assist system (HM3 LVAS)

Patients will be implanted with the HM3 LVAS

Group Type EXPERIMENTAL

HeartMate 3™ left ventricular assist system (HM3 LVAS)

Intervention Type DEVICE

Advanced heart failure patients will be implanted with the HM3 LVAS

Interventions

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HeartMate 3™ left ventricular assist system (HM3 LVAS)

Advanced heart failure patients will be implanted with the HM3 LVAS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria

General Inclusion Criteria: All patients approved for HM3 implantation in Korea as per HIRA guidelines will be eligible to be enrolled in the PMS. Only the patients who provide written informed consent will be included in the study. If a subject has had an outcome after the HM3 implantation but prior to providing informed consent, no consent will be obtained, and a limited anonymized data will be collected.

Exclusion Criteria

General Exclusion Criteria: This post market surveillance does not have specific exclusion criteria

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No