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

NCT07412626 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-02-17

No results posted yet for this 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.

Conditions

  • Congestive Heart Failure Chronic
  • Low Ejection Fraction

Interventions

DEVICE

Heartlogic Diagnostic Tool Threshold Change

Heart Logic threshold set to 10 (from 16)

DEVICE

Heartlogic Diagnostic Tool Unchanged Threshold

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Ascension Health

    collaborator INDUSTRY

  • Robert Pickett

    lead INDUSTRY

Principal Investigators

  • Robert Pickett, MD · Ascension Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07412626 on ClinicalTrials.gov