The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation. The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Implantation of left ventricular assist device for mechanical circulatory support
Universitätsklinikum Graz
Graz, Austria
NOT_YET_RECRUITINGUniversitätskliniken der MedUni Wien
Vienna, Austria
RECRUITINGComposite of surivival
At 6 months post-implantation, composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score \> 3), or re-operation to replace the pump due to pump failure.
Time frame: Up to 6 months post-implantation
Survival
Overall survival of patients
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Composite of surivival
Composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score \> 3), or re-operation to replace the pump due to pump failure.
Time frame: Year 1, Year 2, Year 5
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)
The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Functional status as measured by the Six Minute Walk Test (6MWT)
The more meters a patient can walk over baseline indicates improvement in functional status.
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Functional status as measured by the New York Heart Association (NYHA) Classification
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Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Deutsches Herzzentrum der Charité
Berlin, Germany
RECRUITINGKlinikum Links der Weser
Bremen, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Hamburg
Hamburg, Germany
RECRUITINGUniversitätsklinikums Heidelberg
Heidelberg, Germany
RECRUITINGHerzzentrum Leipzig
Leipzig, Germany
RECRUITINGUniversitätsklinikum Würzburg
Würzburg, Germany
NOT_YET_RECRUITINGIRCCS Ospedale San Raffaele
Milan, Italy
NOT_YET_RECRUITING...and 1 more locations
NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status.
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Adverse Events
Frequency and incidence of all anticipated Adverse Event.
Time frame: As they occurred, from Baseline to Year 5