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Corheart 6 LVAS LTFU

Primary Purpose

End-stage Heart Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Corheart 6 Left Ventricular Assist System
Sponsored by
Shenzhen Core Medical Technology CO.,LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Heart Failure

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 18 years Patient or legal representative has signed Informed Consent Form (ICF) BSA ≥ 1.0 m2 Females of child bearing age must agree to use adequate contraception 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) LVEF ≤ 30%,and at least one of the following conditions occurs: 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; Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs; Meeting diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg; Cardiac discharge index < 2.0; Pulmonary capillary wedge pressure > 18mmHg Exclusion Criteria: Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy,pericardial disease, amyloidosis or restrictive cardiomyopathy. Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests. In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk. 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. Patients require biventricular assist device support. Pregnancies. 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. History of visceral organ transplantation. Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation. TBIL (total bilirubin) > 3.0 mg/dL and serum creatinine (SCr) > 3.0 mg/dL within 48 hours before surgery may require dialysis. History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension。 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. Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter. Severe peripheral vascular disease with resting pain or extremity ulceration. 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. Expect to live less than 1 year if you have a malignant tumor or other disease. Patients participate in any other clinical trials that may influence the results of this study. Other circumstances that are unforeseen and determined by the researcher to be unsuitable.

Sites / Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Corheart 6 LVAS

Arm Description

Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced refractory heart failure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.

Full Information

First Posted
March 17, 2023
Last Updated
June 28, 2023
Sponsor
Shenzhen Core Medical Technology CO.,LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05928273
Brief Title
Corheart 6 LVAS LTFU
Official Title
Corheart 6 Left Ventricular Assist System Long Term Follow-up Clinical Evaluation Plan
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
July 10, 2022 (Actual)
Study Completion Date
January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Core Medical Technology CO.,LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corheart 6 LVAS
Arm Type
Experimental
Arm Description
Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced refractory heart failure.
Intervention Type
Device
Intervention Name(s)
Corheart 6 Left Ventricular Assist System
Intervention Description
Implantation of left ventricular assist device for hemodynamic support
Primary Outcome Measure Information:
Title
Survival [ Time Frame: 6 months ]
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life (EQ-5D-5L)
Description
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.
Time Frame
Baseline, Month 1, Month 3, Month 6
Title
Functional Status - Six Minute Walk Test (6MWT)
Description
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
[ Time Frame: Baseline, Month 1, Month 3, Month 6 ]
Title
New York Heart Association (NYHA) Classification
Description
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
Time Frame
Baseline, Month 1, Month 3, Month 6
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time Frame
Baseline, Month 1, Month 3, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Patient or legal representative has signed Informed Consent Form (ICF) BSA ≥ 1.0 m2 Females of child bearing age must agree to use adequate contraception 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) LVEF ≤ 30%,and at least one of the following conditions occurs: 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; Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs; Meeting diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg; Cardiac discharge index < 2.0; Pulmonary capillary wedge pressure > 18mmHg Exclusion Criteria: Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy,pericardial disease, amyloidosis or restrictive cardiomyopathy. Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests. In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk. 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. Patients require biventricular assist device support. Pregnancies. 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. History of visceral organ transplantation. Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation. TBIL (total bilirubin) > 3.0 mg/dL and serum creatinine (SCr) > 3.0 mg/dL within 48 hours before surgery may require dialysis. History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension。 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. Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter. Severe peripheral vascular disease with resting pain or extremity ulceration. 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. Expect to live less than 1 year if you have a malignant tumor or other disease. Patients participate in any other clinical trials that may influence the results of this study. Other circumstances that are unforeseen and determined by the researcher to be unsuitable.
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Corheart 6 LVAS LTFU

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