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
1 other identifier
interventional
135
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
February 17, 2026
February 1, 2026
1.7 years
February 9, 2026
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalizations
Number of Hospitalizations
365 Days
Secondary Outcomes (2)
Number of ICD Shocks
365 Days
nt-ProBNP
365 days
Study Arms (2)
Active Treatment Arm
ACTIVE COMPARATORHeart Logic threshold set to 10 (from 16) will trigger a treatment algorithm, which includes up titration of GDMT
Control Arm
PLACEBO COMPARATORHeart 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.
Interventions
Heart Logic threshold set to 10 (from 16)
Heartlogic Threshold to remain at 16, which is the normal limit.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Refuse to give consent
- Have Life expectancy of less than one-year
- Documented noncompliance that limits medication use
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert Pickettlead
- Boston Scientific Corporationcollaborator
- Ascension Healthcollaborator
Study Sites (2)
Ascension St. Vincent Medical Group
Indianapolis, Indiana, 46260, United States
Saint Thomas Heart at Saint Thomas Midtown
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Pickett, MD
Ascension Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 17, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.