Recruiting

MyLeukoMAP™

Sponsor:

LeukoLifeDx Inc

Code:

NCT05258942

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

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 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.

Conditions

Heart Failure

Study ID

NCT05258942

Start date

Jul 1, 2022

Status verified date

Jul, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

-

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery

Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery

Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI)

Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI)

Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery

Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery

Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery

Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery

Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR)

Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR)

Heart Failure Patients Scheduled for Transcatheter Mitra Clip

Heart Failure Patients Scheduled for Transcatheter Mitra Clip

Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation

Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation

Heart Failure Patients Scheduled for Stellate Gangliectomy

Heart Failure Patients Scheduled for Stellate Gangliectomy

Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery

Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery

Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery

Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery

Interventions

Observational

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.

Primary outcome measure

  • Survival / Non-Survival [ Time Frame: 1-year (365-455 Days) Post Intervention ]

Central Contacts and Locations

Central contacts

Simran Prajapat, PhD

617.820.3725sprajapat@researchdx.com

Gordon Vansant, PhD

760.473.4295gvansant@researchdx.com

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Lavanya Bellumkonda, MD

203-785-7191lavanya.bellumkonda@yale.edu

Jill Boria, RN

jill.boria@yale.edu

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Nirav Raval, MD

nirav.raval.md@flhosp.org

Jennifer Lyden, BSN

407.303.2988jennifer.lyden@adventhealth.com

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Andrew Kao, MD

816-931-1883akao@cc-pc.com

Brenda Akers, BSN

816.932.1627bakers@saint-lukes.org

More Information

Sponsor

LeukoLifeDx Inc

Last update posted

Oct 27, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LeukoLifeDx Inc on 2022-10-27.