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Clinical Trials in the USA / NCT07412626
Starting soon Not applicable

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

NCT07412626 · tracked via the Priya Life Science USA tracker
Sponsor
Robert Pickett
Phase
Not applicable
Started
2026-04-01
Last updated
2026-02-17

Condition(s) studied

Congestive Heart Failure ChronicLow Ejection Fraction

Investigational drug(s) / intervention(s)

Heartlogic Diagnostic Tool Threshold ChangeHeartlogic Diagnostic Tool Unchanged Threshold

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)

Trial sites (2)

FacilityCityRegionStatus
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.

View NCT07412626 on ClinicalTrials.gov ↗ ← All trials in the USA