Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of Corheart 6 left ventricular assist system by conducting a prospective, multicenter, single-arm, target-value clinical trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
This trial, named "Corheart 6 Left Ventricular Assist System Prospective, Multi-center, Single-group Clinical Evaluation Trial", is designed with 3-month device implantation success rate as the main efficacy indicator, and 50 subjects are planned to be enrolled.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arms and Interventions Experimental: Corheart 6 Left Ventricular Assist System (LVAS) to be used on subjects with advanced refractory left ventricular heart failure. |
Device: Intervention/treatment:
Implantation of left ventricular assist device for hemodynamic support.
Drug: Heparin
Injection of heparin
|
Outcome Measures
Primary Outcome Measures
- Survival [ Time Frame: 3 months ] [Time Frame: 3 months]
The success rate of device implantation at 3 months refers to the proportion of patients meeting the criteria of device success at 3 months.
Secondary Outcome Measures
- Quality of Life (EQ-5D-5L) [Baseline, Month 1, Month 2，Month 3,]
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, two and three months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
- Functional Status - New York Heart Association (NYHA) Classification [Baseline, Month 1, Month 2，Month 3,]
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
- Functional Status - Six Minute Walk Test (6MWT) [Baseline, Month 1, Month 2，Month 3,]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
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Patient or legal representative has signed Informed Consent Form (ICF)
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BSA ≥ 1.0 m2
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Females of child bearing age must agree to use adequate contraception
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Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers and diuretics)
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LVEF ≤ 30%,and at least one of the following conditions occurs:
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For those whose condition cannot be reversed or can't be removed by using intraaortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO) or other short-term mechanical circulation assistance;
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Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs;
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Meeting diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg; Cardiac discharge index < 2.0; Pulmonary capillary wedge pressure > 18mmHg
Exclusion Criteria:
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Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy pericardial disease, amyloidosis or restrictive cardiomyopathy.
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Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
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In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk.
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The patient was intolerant to anticoagulant or antiplatelet therapy or was unable to receive other perioperative and postoperative treatments that the investigator deemed necessary based on the patient's health condition.
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Patients require biventricular assist device support.
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Pregnancies.
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The patient had moderate to severe aortic insufficiency or a history of mechanical aortic valve implantation, but did not agree or could not be corrected by replacement or replacement of biological valve during LVAD implantation.
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History of visceral organ transplantation.
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Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
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TBIL (total bilirubin) > 3.0 mg/dL and serum creatinine (SCr) > 3.0 mg/dL within 48 hours before surgery may require dialysis.
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History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
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Pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmHg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrated that pulmonary vascular resistance did not respond to drug therapy: pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg.
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Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
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Severe peripheral vascular disease with resting pain or extremity ulceration.
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Patients with psychiatric disorders/disorders, irreversible cognitive impairment or psychosocial problems are at risk of failing to comply with research protocols and regulations governing the use of implantable LEFT ventricular assist systems or brain death from various causes.
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Expect to live less than 1 year if you have a malignant tumor or other disease.
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Patients participate in any other clinical trials that may influence the results of this study.
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Other circumstances that are unforeseen and determined by the researcher to be unsuitable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shenzhen Core Medical Technology Co.,Ltd | Shenzhen | Guangdong | China | 51800 |
Sponsors and Collaborators
- Shenzhen Core Medical Technology CO.,LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COREMED_LVAS