HeartLogic Optimization of CHF Medications in Chronic Low EF Population: A Follow-on Study
Robert Pickett
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.
Description
Investigator-sponsored post-market, randomized, multicenter trial evaluating the HeartLogic diagnostic in optimizing GDMT in patients with chronically low EF
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 batter…
Interventions
- DeviceHeartlogic Diagnostic Tool Threshold Change
Heart Logic threshold set to 10 (from 16)
- DeviceHeartlogic Diagnostic Tool Unchanged Threshold
Heartlogic Threshold to remain at 16, which is the normal limit.
Locations (2)
- Ascension St. Vincent Medical GroupIndianapolis, Indiana
- Saint Thomas Heart at Saint Thomas MidtownNashville, Tennessee