Corheart 6 VAS Study

Study Overview
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Brief Summary
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This study is to evaluate the safety and effectiveness of the Corheart 6 Ventricular Assist System (Corheart 6 VAS) when used for the treatment of advanced refractory heart failure.

Official Title
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Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Ventricular Assist System

Conditions
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Refractory Heart Failure

Intervention / Treatment
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* Device: Corheart 6 Ventricular Assist System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years 2. BSA ≥ 1.0 m^2 3. NYHA III or IV OR ACC/AHA Stage D 4. LVEF ≤ 30% 5. Patients must also meet one or more of the following: CI ≤ 2.2 L/min/m², while on Optimal Medical and Device Management, based on current heart failure practice guidelines; OR Impella or IABP assisted patient (based on doctors' judgement); OR Inotrope dependent/unable to wean from inotropes; OR Listed for heart transplantation. Exclusion Criteria: 1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status. 2. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II. 3. Platelet count < 100,000 x 10^3/L (< 100,000/ml). 4. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management. 5. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. 6. Presence of an active, uncontrolled infection. 7. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: a. Total bilirubin > 51.3 umol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score. b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted. c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention. d. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis e. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis. f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration. 8. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis. 9. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant. 10. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter. 11. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF). 12. STEMI <2 weeks before planned implantation. 13. Right ventricular failure as defined by one or more of the following: a. severe depressed RV function in echocardiography b. TAPSE < 1.0 cm c. PCWP/CVP <0.63 14. Planned Bi-VAD support prior to enrollment. 15. History of any organ transplant. 16. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL). 17. Any condition other than HF that could limit survival to less than 24 months. 18. Positive pregnancy test if of childbearing potential. 19. Lactating mothers. 20. Participation in any other clinical investigation that is likely to confound study results or affect the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corheart 6 VAS<br>Corheart 6 Ventricular Assist System (Corheart 6 VAS) to be used on patients with advanced refractory heart failure. | Device: Corheart 6 Ventricular Assist System<br>* Implantation of ventricular assist device for hemodynamic support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | At 6 months post-implantation, composite of survival to transplant, recovery or VAS support free of disabling stroke (Modified Rankin Score > 3) or re-operation to replace the pump due to pump failure. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall survival of patients | Year 1, Year 2, Year 3, Year 4, Year 5 | 
| Quality of Life as measured by the 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 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | 
| Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) | 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. | Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | 
| Functional status as measured by the Six Minute Walk Test (6MWT) | The more meters a patient can walk over baseline indicates improvement in functional status. | Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | 
| Functional status as measured by the New York Heart Association (NYHA) Classification | 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. | Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | 
| Adverse Events | Frequency and incidence of all anticipated Adverse Event. | As they occurred, from Baseline to Year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced heart failure; ventricular assist system;