Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)
Heartlogic Diagnostic Tool Threshold Change: Heart Logic threshold set to 10 (from 16)
Heartlogic Diagnostic Tool Unchanged Threshold: Heartlogic Threshold to remain at 16, which is the normal limit.
Study summary
The goal of this trial is to determine if the addition of the Heart Logic diagnostic alerts to standard of care therapies will lessen hospitalizations and improve quality of life in patients with heart failure.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age 18 years or older
* EF \</=35%
* Prior hospitalization within the last two years or prior decompensation to NYHA class III or IV over the last 12 months that was treated without hospitalization
* HeartLogic capable ICD or CRT-D (Patients with HeartLogic capable ICD or CRT-D can be enrolled at time of de novo implantation or generator change out or at the time of the 2 week wound check. Prior Heart logic capable ICF or CRT-D implants can be enrolled if heart failure hospitalization shows decompensation within six months (prior implants must have at least 1 year battery life)
Exclusion Criteria:
* Refuse to give consent
* Have Life expectancy of less than one-year
* Documented noncompliance that limits medication use
* Patients on Dialysis (renal insufficiency but not on dialysis is NOT an exclusion)
* Pregnancy
Primary outcome measure(s)
Hospitalizations — 365 Days Number of Hospitalizations
Trial sites (2)
Facility
City
Region
Status
Ascension St. Vincent Medical Group
Indianapolis
Indiana
Saint Thomas Heart at Saint Thomas Midtown
Nashville
Tennessee
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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