HeartMate 3 CE Mark Study Long Term Follow-up

Advanced Refractory Left Ventricular Heart Failure Clinical Trial

— HM3 CE LTFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022461
• Other study ID #: HeartMate 3 CE Mark Study LTFU
• Status: Completed
• Start date: June 23, 2014
• Est. completion date: December 12, 2019

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Refractory Left Ventricular Heart Failure
• Heart Failure

Intervention

Other:
• Long term follow-up

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Austria	AKH Medical University of Vienna	Vienna
Canada	Toronto General Hospital	Toronto	Ontario
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Prague
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitats-Herzzentrum Freiburg	Freiburg
Germany	Medizinische Hochschule Hannover	Hannover
Kazakhstan	National Research Center for Cardiac Surgery	Astana

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  Czechia,  Germany,  Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Subject outcomes and survival over time	At 5 years post HM3 CE Mark study implant
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events	Number of Participants with Adverse Events	Between 2 and 5 years post HM3 CE Mark study implant
Secondary	Device Malfunctions	Number of Participants with device malfunctions	Between 2 and 5 years post HM3 CE Mark study implant
Secondary	Reoperations	Number of reoperations	Between 2 and 5 years post HM3 CE Mark study implant
Secondary	Rehospitalizations	Number of rehospitalizations	Between 2 and 5 years post HM3 CE Mark study implant
Secondary	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