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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.
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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.
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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
300 participants in 10 patient groups
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Central trial contact
Gordon Vansant, PhD; Simran Prajapat, PhD
Data sourced from clinicaltrials.gov
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