Corheart 6 LVAS LTFU

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

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.

Study Overview

• Status: Completed
• Conditions: End-stage Heart Failure
• Intervention / Treatment: Device: Corheart 6 Left Ventricular Assist System

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corheart 6 LVAS; Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced refractory heart failure.	Device: Corheart 6 Left Ventricular Assist System; Implantation of left ventricular assist device for hemodynamic support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 ]
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
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

Collaborators and Investigators

• Sponsor: Shenzhen Core Medical Technology CO.,LTD.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: COREMED_LVAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No