Corheart 6 LVAS LTFU

End-stage Heart Failure Clinical Trial

Official title:

Corheart 6 Left Ventricular Assist System Long Term Follow-up Clinical Evaluation Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05928273
• Other study ID #: COREMED_LVAD
• Status: Completed
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: January 17, 2023

Study information

• Verified date: March 2023
• Source: Shenzhen Core Medical Technology CO.,LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 17, 2023
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Patient or legal representative has signed Informed Consent Form (ICF)

3. BSA = 1.0 m2

4. Females of child bearing age must agree to use adequate contraception

5. 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)

6. LVEF = 30%,and at least one of the following conditions occurs:

1. For those whose condition cannot be reversed or can't be removed by using intraaortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO) orother short-term mechanical circulation assistance;

2. Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs;

3. Meeting diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg; Cardiac discharge index < 2.0; Pulmonary capillary wedge pressure > 18mmHg

Exclusion Criteria:

1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy,pericardial disease, amyloidosis or restrictive cardiomyopathy.

2. Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.

3. In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk.

4. 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.

5. Patients require biventricular assist device support.

6. Pregnancies.

7. 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.

8. History of visceral organ transplantation.

9. Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.

10. TBIL (total bilirubin) > 3.0 mg/dL and serum creatinine (SCr) > 3.0 mg/dL within 48 hours before surgery may require dialysis.

11. History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension?

12. 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.

13. Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.

14. Severe peripheral vascular disease with resting pain or extremity ulceration.

15. 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.

16. Expect to live less than 1 year if you have a malignant tumor or other disease.

17. Patients participate in any other clinical trials that may influence the results of this study.

18. Other circumstances that are unforeseen and determined by the researcher to be unsuitable.

Related Conditions & MeSH terms

• End-stage Heart Failure
• Heart Failure

Intervention

Device:
• Corheart 6 Left Ventricular Assist System
Implantation of left ventricular assist device for hemodynamic support

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Core Medical Technology CO.,LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival [ 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.	6 months
Secondary	Quality of Life (EQ-5D-5L)	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.	Baseline, Month 1, Month 3, Month 6
Secondary	Functional Status - Six Minute Walk Test (6MWT)	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 ]
Secondary	New York Heart Association (NYHA) Classification	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	Baseline, Month 1, Month 3, Month 6
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.	Baseline, Month 1, Month 3, Month 6