HeartMate 3 CE Mark Study Long Term Follow-up

Completed

Conditions: Advanced Refractory Left Ventricular Heart Failure

Interventions: Other: Long term follow-up

Registration Number: NCT03022461

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Survival	At 5 years post HM3 CE Mark study implant	Subject outcomes and survival over time

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Between 2 and 5 years post HM3 CE Mark study implant	Number of Participants with Adverse Events
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	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
Device Malfunctions	Between 2 and 5 years post HM3 CE Mark study implant	Number of Participants with device malfunctions
EuroQoL 5D-5L (EQ-5D-5L) VAS Score	At 5 years post HM3 CE Mark study implant	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
New York Heart Association (NYHA)	At 5 years post HM3 CE Mark study implant	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.
Rehospitalizations	Between 2 and 5 years post HM3 CE Mark study implant	Number of rehospitalizations
Six Minute Walk Test (6MWT)	At 5 years post HM3 CE Mark study implant	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
Reoperations	Between 2 and 5 years post HM3 CE Mark study implant	Number of reoperations

Trial Locations

Locations (8): Deutsches Herzzentrum Berlin
🇩🇪
Berlin, Germany
Institute for Clinical and Experimental Medicine (IKEM)
🇨🇿
Prague, Czechia
AKH Medical University of Vienna
🇦🇹
Vienna, Austria
Medizinische Hochschule Hannover
🇩🇪
Hannover, Germany
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
Universitats-Herzzentrum Freiburg
🇩🇪
Freiburg, Germany
National Research Center for Cardiac Surgery
🇰🇿
Astana, Kazakhstan
Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada