Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)

HeartLogic Optimization of CHF Medications in Chronic Low EF Population: A Follow-on Study

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.

Investigator-sponsored post-market, randomized, multicenter trial evaluating the HeartLogic diagnostic in optimizing GDMT in patients with chronically low EF

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