Heart Failure
Conditions
Brief summary
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.
Interventions
Implantation of left ventricular assist device for hemodynamic support
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Age ≥ 18 years. * 2\. The patient or legal representative is willing to participate in the study and offers informed consent. * 3\. Body surface area (BSA) ≥ 1.0 m\^2. * 4\. Females of childbearing age must agree to use adequate contraception. * 5\. Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by standardized treatment with oral anti-heart failure drugs. * 6\. Left Ventricular Ejection Fraction (LVEF) ≤ 35%, and at least one of the following conditions occurs: * a. Fail to be reversed by or be weaned from intra-aortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO), or other short-term mechanical circulatory support. * b. Rely on continuous intravenous administration of one or more vasoactive or inotropic drugs. * c. Meeting the diagnostic criteria of cardiogenic shock: blood pressure \< 90/60mmHg, cardiac index \< 2.0 L/min/m\^2 (optional), and pulmonary capillary wedge pressure \> 18mmHg (optional).
Exclusion criteria
* 1\. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease. * 2\. Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests. * 3\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. * 4\. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status. * 5\. Patients require bi-ventricular assist device support. * 6\. Pregnancy. * 7\. Presence of moderate to severe aortic insufficiency or a history of the mechanical aortic valve that will not be converted to a bioprosthesis or oversewn at the time of implantation. * 8\. History of any organ transplantation. * 9\. Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation. * 10\. TBIL (total bilirubin) \> 3.0 mg/dL within 48 hours prior to implantation. * 11\. Serum creatinine (SCr) \> 3.0 mg/dL within 48 hours prior to implantation or may require dialysis. * 12\. Presence of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension. * 13\. Presence of pulmonary embolism within 3 weeks prior to implantation. * 14\. Pulmonary artery systolic pressure exceeds 60mmHg, combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy: * a. Pulmonary vascular resistance greater than 8 wood units. * b. The transpulmonary differential pressure exceeds 20mmHg. * 15\. Established and untreated abdominal or thoracic aortic aneurysm \> 5cm in diameter. * 16\. Presence of severe peripheral vascular disease with resting pain or extremity ulceration. * 17\. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management, or brain death from various causes. * 18\. History of documented disabling stroke within 90 days prior to implantation, a history of cerebrovascular disease, or the presence of uncorrected severe bilateral carotid artery stenosis. * 19\. History of acute myocardial infarction within 60 days prior to implantation, judged by the investigator to have a risk of myocardial rupture or other surgical high-risk difficult-to-control bleeding, etc. * 20\. Expected lifetime of less than 1 year due to malignant tumor or other disease. * 21\. Participation in any other clinical study that may influence the results of this study. * 22\. Other circumstances that are unforeseen and determined by the researcher to be unsuitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device implantaion success rate at 24 months post-implantation | Up to 24 months post-implantation | Device implantation success is defined as: * A. Electively transplanted or explanted prior to 24 months or * B. Alive at 24 months, and * I. Have not experienced a stroke with a modified Rankin Score \> 3, and * II. Have not received a device replacement or exchange due to a device malfunction, and * III. Have not received an urgent transplant due to a device malfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation | The scores from the 5 dimensions are summed for the total score, with higher scores indicating more problems and a worse quality of life. |
| Functional status as measured by the Six Minute Walk Test (6MWT) | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation | The more meters a patient can walk over baseline indicates improvement in functional status. |
| Functional status as measured by the New York Heart Association (NYHA) Classification | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation | 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. |
| Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score | 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 | Scores range from 0 to 42. Higher scores indicate more severe disability |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) | Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation | Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms. |
| Adverse events | As they occur, from baseline to 24 months post-implantaion | Frequency and incidence of all anticipated adverse events |
| Device-related re-operations | As they occur, from baseline to 24 months post-implantaion | Frequency and incidence of all device-related re-operations |
| Device-related re-hospitalizations | As they occur, from initial hospital discharge to 24 months post-implantation | Frequency and incidence of all device-related re-hospitalizations |
| Overall survival | Up to 60 months post-implantation | Overall survival at 60 months post-implantation |
| Stroke severity as assessed by the modified Rankin Scale (mRS) score | 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 | Scores range from 0 to 6. Higher scores indicate more severe disability |
Countries
China
Contacts
Primary ContactZhibing Qiu
Outcome results
None listed