Hong Kong and Taiwan HM3 PMS

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2022-06-30

Brief Summary

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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.

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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

\- 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No