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The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corheart 6 LVAS | Experimental | Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corheart 6 Left Ventricular Assist System | Device | Implantation of left ventricular assist device for hemodynamic support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device implantaion success rate at 24 months post-implantation | Device implantation success is defined as:
| Up to 24 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) | Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms. | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation |
| Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhibing Qiu | Contact | 025-52271064 | qiuzhibing2009@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhibing Qiu | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The scores from the 5 dimensions are summed for the total score, with higher scores indicating more problems and a worse quality of life. |
| Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation |
| 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. | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation |
| Functional status as measured by the New York Heart Association (NYHA) Classification | 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. | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation |
| Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score | Scores range from 0 to 42. Higher scores indicate more severe disability | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation |
| Stroke severity as assessed by the modified Rankin Scale (mRS) score | Scores range from 0 to 6. Higher scores indicate more severe disability | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation |
| Adverse events | Frequency and incidence of all anticipated adverse events | As they occur, from baseline to 24 months post-implantaion |
| Device-related re-operations | Frequency and incidence of all device-related re-operations | As they occur, from baseline to 24 months post-implantaion |
| Device-related re-hospitalizations | Frequency and incidence of all device-related re-hospitalizations | As they occur, from initial hospital discharge to 24 months post-implantation |
| Overall survival | Overall survival at 60 months post-implantation | Up to 60 months post-implantation |