Status:
UNKNOWN
MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study
Lead Sponsor:
LeukoLifeDx Inc
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 Fail...
Detailed Description
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 Fail...
Eligibility Criteria
Inclusion
- 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 #1: No informed consent Criteria #2: \<18 years old
- \-
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05258942
Start Date
July 1 2022
End Date
August 1 2023
Last Update
October 27 2022
Active Locations (3)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
AdventHealth Orlando
Orlando, Florida, United States, 32803
3
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111