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NCT Number: NCT07412626

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ascension St. Vincent Medical Group, Indianapolis, Indiana, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heartlogic Diagnostic Tool Threshold Change

Device

Heart Logic threshold set to 10 (from 16)

Heartlogic Diagnostic Tool Unchanged Threshold

Device

Heartlogic Threshold to remain at 16, which is the normal limit.

Primary outcomes

  1. Hospitalizations

    Time frame: 365 Days

    Number of Hospitalizations

Secondary outcomes

  1. Number of ICD Shocks

    Time frame: 365 Days

    Number of ICD shocks due to VT, VF and changes to AFib burden

  2. nt-ProBNP

    Time frame: 365 days

    Changes to nt-proBNP

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Pickett, MD

CONTACT

[email protected]

615-329-5144

Saint Thomas Heart at Saint Thomas Midtown

CONTACT

615-329-5144

Sponsors and collaborators

Lead sponsor

Robert Pickett

Industry

Collaborators

  • Ascension Health
  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: Heartlogic ISR

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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