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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Refractory Left Ventricular Heart Failure
• Intervention / Treatment: Other: Long term follow-up

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • The Alfred Hospital
• Austria
  • Vienna, Austria, A-1090
    • AKH Medical University of Vienna
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2C4
      • Toronto General Hospital
• Czechia
  • Prague, Czechia, 4
    • Institute for Clinical and Experimental Medicine (IKEM)
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Freiburg, Germany, 79106
    • Universitats-Herzzentrum Freiburg
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
• Kazakhstan
  • Astana, Kazakhstan, 010000
    • National Research Center for Cardiac Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Subject outcomes and survival over time	At 5 years post HM3 CE Mark study implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQoL 5D-5L (EQ-5D-5L) VAS Score	Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life	At 5 years post HM3 CE Mark study implant
Six Minute Walk Test (6MWT)	Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes	At 5 years post HM3 CE Mark study implant
New York Heart Association (NYHA)	Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms: I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.	At 5 years post HM3 CE Mark study implant
Adverse Events	Number of Participants with Adverse Events	Between 2 and 5 years post HM3 CE Mark study implant
Device Malfunctions	Number of Participants with device malfunctions	Between 2 and 5 years post HM3 CE Mark study implant
Reoperations	Number of reoperations	Between 2 and 5 years post HM3 CE Mark study implant
Rehospitalizations	Number of rehospitalizations	Between 2 and 5 years post HM3 CE Mark study implant
Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)	Modified Rankin Score >3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed. The MRS scale is as following: 0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead	As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Carlo Gazzola, B. Sc., Abbott

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2014
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiovascular Disease; Heart Disease; Thoratec Corporation; Ventricular Dysfunction; Cardiomyopathies; Heart-assist Devices
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HeartMate 3 CE Mark Study LTFU