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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congestive Heart Failure Chronic; Low Ejection Fraction
• Intervention / Treatment: Device: Heartlogic Diagnostic Tool Threshold Change; Device: Heartlogic Diagnostic Tool Unchanged Threshold

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Pickett, MD; Phone Number: 615-329-5144; Email: robert.pickett@ascension.org
• Study Contact Backup: Name: Saint Thomas Heart at Saint Thomas Midtown; Phone Number: 615-329-5144

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Ascension St. Vincent Medical Group
      • Principal Investigator: Jasen Gilge, MD
      • Contact: Jasen Gilge, MD; Phone Number: 317-338-6666; Email: Jasen.gilge@ascension.org
      • Contact: Ascension St. Vincent Medical Group; Phone Number: 317-338-6666
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Saint Thomas Heart at Saint Thomas Midtown
      • Principal Investigator: Robert Pickett, MD
      • Contact: Robert Pickett, MD; Phone Number: 615-329-5144; Email: robert.pickett@ascension.org
      • Contact: Saint Thomas Heart at Saint Thomas Midtown; Phone Number: 615-329-5144

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment Arm; Heart Logic threshold set to 10 (from 16) will trigger a treatment algorithm, which includes up titration of GDMT	Device: Heartlogic Diagnostic Tool Threshold Change; Heart Logic threshold set to 10 (from 16)
Placebo Comparator: Control Arm; Heart Logic transmission of 16 or greater may be reported to the appropriate device clinic staff by Latitude transmission and then referred to the appropriate treating provider. Medication changes will be based upon physician preference/standards. Repeat transmissions, follow-up, laboratory studies will be per physician preference.	Device: Heartlogic Diagnostic Tool Unchanged Threshold; Heartlogic Threshold to remain at 16, which is the normal limit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations	Number of Hospitalizations	365 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ICD Shocks	Number of ICD shocks due to VT, VF and changes to AFib burden	365 Days
nt-ProBNP	Changes to nt-proBNP	365 days

Collaborators and Investigators

• Sponsor: Robert Pickett
• Collaborators: Boston Scientific Corporation; Ascension Health
• Investigators: Principal Investigator: Robert Pickett, MD, Ascension Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: RTN20250021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the investigator(s) and personnel involved in the conduct of the investigation will have access to data collected during the course of this investigation. All reasonable means will be used to maintain confidentiality of data, including password protected, restricted access to data. Paper records will be maintained in locked and secure locations accessible only to study personnel.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No