Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)
Starting soon · Not applicable
Conditions studied: Congestive Heart Failure Chronic, Low Ejection Fraction
In brief
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.
Key facts
- Study ID
- NCT07412626
- Run by
- Robert Pickett
- People needed
- 135
- Starts
- 2026-04-01
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Ascension St. Vincent Medical Group — Indianapolis, Indiana, United States
- Saint Thomas Heart at Saint Thomas Midtown — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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