Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037, China
NCT Number: NCT05928273
This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) when used for the treatment of advanced refractory heart failure.
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Notify Me19 year–75 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100037, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of left ventricular assist device for hemodynamic support
Time frame: 6 months
Patients survived with the device for at least 6 months without disabling stroke (disabling stroke disabling stroke defined as a mRS Score > 3 at 60 days after stroke) and without reoperation (replacement or removal) due to device problems.
Time frame: Baseline, Month 1, Month 3, Month 6
The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
Time frame: [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]
The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes.The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
Time frame: Baseline, Month 1, Month 3, Month 6
NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Time frame: Baseline, Month 1, Month 3, Month 6
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Shenzhen Core Medical Technology CO.,LTD.
Industry
Corheart 6 Left Ventricular Assist System Long Term Follow-up Clinical Evaluation Plan
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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