HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan

Abbott Medical Devices8 sites in 6 countries25 target enrollmentJune 23, 2014

ConditionsAdvanced Refractory Left Ventricular Heart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Refractory Left Ventricular Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 25
Locations: 8
Primary Endpoint: Survival
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 23, 2014

End Date

December 12, 2019

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient or legal representative has signed Informed Consent Form (ICF).
•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.

Exclusion Criteria

•Patient does not consent to the continued data collection.

Outcomes

Primary Outcomes

Survival

Time Frame: At 5 years post HM3 CE Mark study implant

Subject outcomes and survival over time

Secondary Outcomes

Adverse Events(Between 2 and 5 years post HM3 CE Mark study implant)
Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)(As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first)
Device Malfunctions(Between 2 and 5 years post HM3 CE Mark study implant)
EuroQoL 5D-5L (EQ-5D-5L) VAS Score(At 5 years post HM3 CE Mark study implant)
New York Heart Association (NYHA)(At 5 years post HM3 CE Mark study implant)
Rehospitalizations(Between 2 and 5 years post HM3 CE Mark study implant)
Six Minute Walk Test (6MWT)(At 5 years post HM3 CE Mark study implant)
Reoperations(Between 2 and 5 years post HM3 CE Mark study implant)