Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
Primary Purpose
Critical or Chronic Advanced Heart Failure
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intervention/treatment:
Sponsored by
About this trial
This is an interventional treatment trial for Critical or Chronic Advanced Heart Failure
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) or other 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
- Shenzhen Core Medical Technology Co.,Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arms and Interventions
Arm Description
Experimental: Corheart 6 Left Ventricular Assist System (LVAS) to be used on subjects with advanced refractory left ventricular heart failure.
Outcomes
Primary Outcome Measures
Survival [ 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)
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
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)
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.
Full Information
NCT ID
NCT05353816
First Posted
April 26, 2022
Last Updated
February 14, 2023
Sponsor
Shenzhen Core Medical Technology CO.,LTD.
1. Study Identification
Unique Protocol Identification Number
NCT05353816
Brief Title
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
Official Title
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
October 8, 2022 (Actual)
Study Completion Date
January 12, 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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical or Chronic Advanced Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To evaluate the safety and effectiveness of Corheart 6 implantable left ventricular assist system for short and long term circulatory support.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arms and Interventions
Arm Type
Experimental
Arm Description
Experimental: Corheart 6 Left Ventricular Assist System (LVAS) to be used on subjects with advanced refractory left ventricular heart failure.
Intervention Type
Device
Intervention Name(s)
Intervention/treatment:
Intervention Description
Implantation of left ventricular assist device for hemodynamic support.
Primary Outcome Measure Information:
Title
Survival [ Time Frame: 3 months ]
Description
The success rate of device implantation at 3 months refers to the proportion of patients meeting the criteria of device success at 3 months.
Time Frame
Time Frame: 3 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, two and three months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
Time Frame
Baseline, Month 1, Month 2,Month 3,
Title
Functional Status - 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 2,Month 3,
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
Baseline, Month 1, Month 2,Month 3,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) or other 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
Shenzhen Core Medical Technology Co.,Ltd
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
51800
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
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