Clinical trial NCT03022461: HeartMate 3 CE Mark Study Long Term Follow-up
Official title: HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Refractory Left Ventricular Heart Failure
Keywords: Heart Failure
Ventricular Dysfunction
Cardiomyopathies
Heart Disease
Cardiovascular Disease
Heart-assist Devices
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-01-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced refractory left ventricular heart failure who were implanted with HeartMate 3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up will be enrolled in this study.

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.


Eligibility criteria: 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.

Exclusion Criteria:

1. Patient does not consent to the continued data collection.

Primary outcomes:
measure: Survival
timeFrame: At 5 years post HM3 CE Mark study implant
Secondary outcomes:
measure: EuroQoL 5D-5L (EQ-5D-5L) VAS Score
timeFrame: At 5 years post HM3 CE Mark study implant
measure: Six Minute Walk Test (6MWT)
timeFrame: At 5 years post HM3 CE Mark study implant
measure: New York Heart Association (NYHA)
timeFrame: At 5 years post HM3 CE Mark study implant
measure: Adverse Events
timeFrame: Between 2 and 5 years post HM3 CE Mark study implant
measure: Device Malfunctions
timeFrame: Between 2 and 5 years post HM3 CE Mark study implant
measure: Reoperations
timeFrame: Between 2 and 5 years post HM3 CE Mark study implant
measure: Rehospitalizations
timeFrame: Between 2 and 5 years post HM3 CE Mark study implant
measure: Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)
timeFrame: As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Vienna
country: Austria
facility: AKH Medical University of Vienna
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Freiburg
country: Germany
facility: Universitats-Herzzentrum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Astana
country: Kazakhstan
facility: National Research Center for Cardiac Surgery
Study officials:
affiliation: Abbott
name: Carlo Gazzola, B. Sc.
role: STUDY_DIRECTOR
References: