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.
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)
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)
Parallel
Heartlogic Diagnostic Tool Threshold Change
DeviceHeart Logic threshold set to 10 (from 16)
Heartlogic Diagnostic Tool Unchanged Threshold
DeviceHeartlogic Threshold to remain at 16, which is the normal limit.
Hospitalizations
Number of Hospitalizations
Number of ICD Shocks
Number of ICD shocks due to VT, VF and changes to AFib burden
nt-ProBNP
Changes to nt-proBNP
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Robert Pickett
Lead sponsor
Ascension Health
Sponsor institution
Boston Scientific Corporation
Collaborator
Ascension Health
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
