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HeartMate 3 CE Mark Study Long Term Follow-up (HM3 CE LTFU)

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ClinicalTrials.gov Identifier: NCT03022461
Recruitment Status : Active, not recruiting
First Posted : January 16, 2017
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.


Condition or disease Intervention/treatment
Advanced Refractory Left Ventricular Heart Failure Other: Long term follow-up

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
Study Start Date : June 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
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.
Other: Long term follow-up



Primary Outcome Measures :
  1. Survival [ Time Frame: All Subjects will be followed for 3, 4 and 5 years post HM3 CE Mark study implant or to Outcome (transplant, explant, or death), whichever occurs first ]
    Subject outcomes and survival over time


Secondary Outcome Measures :
  1. EuroQoL 5D-5L (EQ-5D-5L) [ Time Frame: 3, 4 and 5 years post HM3 CE Mark study implant ]
    Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L)

  2. Six Minute Walk Test (6MWT) [ Time Frame: 3, 4 and 5 years post HM3 CE Mark study implant ]
    Functional status over time as measured by the Six Minute Walk Test (6MWT)

  3. New York Heart Association (NYHA) [ Time Frame: 3, 4 and 5 years post HM3 CE Mark study implant ]
    Functional status over time as measured by New York Heart Association (NYHA)

  4. Adverse Events [ Time Frame: As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first ]
    Frequency and incidence of pre-defined anticipated adverse event rates

  5. Device Malfunctions [ Time Frame: As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first ]
    Frequency and incidence of device malfunction rates

  6. Reoperations [ Time Frame: As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first ]
    Frequency and incidence of reoperations

  7. Rehospitalizations [ Time Frame: As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first ]
    Frequency and incidence of rehospitalizations

  8. Survival Free of Debilitating Stroke (Modified Rankin Score >3) [ Time Frame: As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022461


Locations
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Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3000
Austria
AKH Medical University of Vienna
Vienna, Austria, A-1090
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4
Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia, 4
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Universitats-Herzzentrum Freiburg
Freiburg, Germany, 79106
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Kazakhstan
National Research Center for Cardiac Surgery
Astana, Kazakhstan, 010000
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Poornima Sood, MD, MBA Abbott

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03022461     History of Changes
Other Study ID Numbers: HeartMate 3 CE Mark Study LTFU
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

Keywords provided by Abbott Medical Devices:
Heart Failure
Ventricular Dysfunction
Cardiomyopathies
Heart Disease
Cardiovascular Disease
Heart-assist Devices
Thoratec Corporation

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases