Advanced Heart Failure
Conditions
Keywords
Biventricular Heart Failure, Biventricular Assist Device, Mechanical Circulatory Support
Brief summary
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support. Each subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.
Interventions
DEVICEDuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
Implantation of the DuoCor 2 Ventricular Assist System for mechanical circulatory support.
Sponsors
Shenzhen Core Medical Technology CO.,LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1.18 years ≤ Age ≤ 75 years * 2.INTERMACS Class 1-2 * 3.Patient is inotrope dependent, OR has a Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes * 4\. Patient has reduced exercise capacity due to cardiac factors with at least one of the following criteria: * Unable to exercise * 6-minute walking test (6MWT) \< 300 meters * 5.Patient has right heart failure related symptoms such as lower limbs edema, jugular vein distension * 6.Patient has advanced, irreversible biventricular heart failure and is deemed to be eligible for biventricular mechanical circulatory support by clinical expertise. * 6a: advanced left heart failure * Left ventricular ejection fraction (LVEF) ≤ 30%; * Pulmonary capillary wedge pressure (PCWP) \> 15mmHg. * 6b: severe right heart failure despite guideline-directed medical therapy. This includes at least one evaluation index of right ventricular function and at least one evaluation index of volume load or structural abnormality: * Evaluation index of right ventricular function: * Right ventricular ejection fraction (RVEF)≤ 30%; * Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\*L/m2; * Right ventricle fractional area change(RVFAC) \< 30%; * Evaluation index of volume load or structural abnormality: * Central venous pressure (CVP)\> 15 mmHg; * CVP to PCWP ratio\> 0.63; * Moderate to severe tricuspid regurgitation; * Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\> 0.72; * Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm; * Pulmonary artery pressure index (PAPi)\< 2. * 7.Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.
Exclusion criteria
* 1.Known intolerance to anticoagulant or antiplatelet therapies. * 2.Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease) * 3.Coagulopathy defined by platelets \< 100\*10\^9/L or INR ≥ 1.5 not due to anticoagulant therapy. * 4\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. * 5\. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days. * 6\. Presence of ECMO with a duration greater than 10 days. * 7.Moderate to severe aortic valve regurgitation or pulmonary valve regurgitation, and refusal of bioprosthetic valve replacement. * 8.Presence of mechanical aortic valve or pulmonary valve, and refusal of bioprosthetic valve replace. * 9\. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device. * 10\. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation. * 11\. Presence of significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration. * 12\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: * Total bilirubin \> 3.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy; * Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 or renal replacement therapy dependence; * History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, and FEV1 \< 50% predicted. * 13\. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units. * 14\. Severe systemic light-chain amyloidosis. * 15\. Blood stream infection within 7 days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion. * 16\. Sepsis * 17\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter. * 18.Any condition other than HF that could limit survival to less than 24 months. * 19.Positive pregnancy test if of childbearing potential, lactating mothers. * 20.Presence of psychiatric disorders, irreversible cognitive impairment, or psychosocial issues that may compromise their ability to comply with the study protocol and management requirements for implantable ventricular assist devices, or brain death due to any cause. * 21\. Participation in any other clinical investigation that is likely to confound study results or affect the study. * 22.Ineligibly based on physician's judgement due to other severe conditions or other conditions which can interfere with subject's compliance to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival rate at 6 months post-implantation | 6 months | Event-free survival rate at 6 months post-implantation. Events are defined as all-cause death, ECMO implantation, and IABP implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function Status as measured by Six Minute Walk Test (6MWT) | Baseline, Month 6, Month 12, Month 24 | The more meters a patient can walk over baseline indicates improvement in functional status. |
| Functional status as measured by the New York Heart Association (NYHA) Classification | Baseline, Month 6, Month 12, Month 24 | NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. |
| Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) | Baseline, Month 6, Month 12, Month 24 | The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life. |
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline, Month 6, Month 12, Month 24 | The scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms. |
| Unplanned Rehospitalization | Month 3, Month 6, Month 12, Month18, Month 24 | Rate of unplanned readmissions to the hospital |
| Event-free survival rate within 24 months post-implantation. | Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24 | Event-free survival rate within 24 months post-implantation. Events are defined as all-cause death, ECMO implantation, and IABP implantation. |
| Adverse Events | Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24 | Frequency and incidence of all Adverse Event as defined in (INTERMACS Adverse Events Definition Date: 10/11/2021) |
Countries
China
Contacts
CONTACTLily Shi
PRINCIPAL_INVESTIGATORNianguo Dong
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed