HeartMate 3 CE Mark Study Long Term Follow-up

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

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-23

Study Completion Date

2019-12-12

Brief Summary

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The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.

The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.

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Detailed Description

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Conditions

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Advanced Refractory Left Ventricular Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ongoing HM3 CE Mark study patients

The study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.

Long term follow-up

Intervention Type OTHER

Interventions

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Long term follow-up

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient or legal representative has signed Informed Consent Form (ICF).
2. Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.