MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study

Study Overview
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Brief Summary
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The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.

Detailed Description
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The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools. Patients scheduled for one of 10 different Heart Failure surgical / interventional therapies will be identified and consented. Four clinical parameters will be collected for each patient: age, white blood cell count, blood pressure, and respiratory rate. Blood samples will be collected concurrent with a routine preoperative blood draw, and peripheral blood mononuclear cells (PBMC's) will be isolated. The PBMC samples will be shipped to ResearchDx, Irvine, CA, for testing using the MyLeukoMAP™ genomic survival prediction assay. Patient 1-year postoperative survival/non-survival data will be reported for each patient. The samples will be tested 1-year after the intervention of the last enrolled patient, and the data will be compared to actual patient 1-year survival to determine the survival prediction accuracy of the assay. The investigators anticipate that the assay will better identify those 20% of patients who currently do not achieve 1-year postoperative survival, and who would have better odds of survival by remaining on medical therapy, but who cannot be identified with current tools.

Official Title
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MyLeukoMAP™ Genomic Survival Prediction Assay for Heart Failure Pivotal Clinical Study

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria #1: AdHF with NYHA III/IV Criteria #2: Left Ventricular Ejection Fraction (LVEF) <35% or >2+valvular disease severity & >low risk Society of Thoracic Surgeons (STS)-score Criteria #3: Evaluation for interventions including CABG/PCI (Stratum #1, Ischemia), Surgical Valve Replacement/TAVR/Mitra-Clip (Stratum #2, Overload), VT-Ablation/Stellate Gangliectomy (Stratum #3, Arrhythmia), or MCS/HTx (Stratum #4, Contractility) - Exclusion Criteria: Criteria #1: No informed consent Criteria #2: <18 years old -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery<br>Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI)<br>Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI) | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery<br>Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery<br>Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR)<br>Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR) | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Transcatheter Mitra Clip<br>Heart Failure Patients Scheduled for Transcatheter Mitra Clip | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation<br>Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Stellate Gangliectomy<br>Heart Failure Patients Scheduled for Stellate Gangliectomy | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery<br>Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|
| Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery<br>Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery | Other: Observational<br>* Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival / Non-Survival | Patient Survival Status | 1-year (365-455 Days) Post Intervention |