Corheart 6 LVAS Study
ConditionRefractory Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Core Medical Technology CO.,LTD.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age ≥ 18 years and ≤ 75 years
2. The patient has signed an Informed Consent Form
3. Body Surface Area (BSA) ≥ 1.2 m²
4. New York Heart Association (NYHA) Class IV
Disqualifiers
1. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
2. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
3. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
4. Platelet count < 100,000 x 10^3/L (< 100,000/ml).
Trial design
Design model
Single group
Treatments tested in this trial
Corheart 6 Left Ventricular Assist System
DeviceImplantation of left ventricular assist device for mechanical circulatory support
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: Corheart 6 LVASExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Composite 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-implantationSecondary outcomes
1
Survival
Overall survival of patients
Time frame
Year 1, Year 2, Year 3, Year 4, Year 52
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 53
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 54
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 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov