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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07412626

Acronym

Heartlogic ISR

Enrollment

135

Registered

2026-02-17

Start date

2026-04-01

Completion date

2028-03-01

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure Chronic, Low Ejection Fraction

Keywords

Heart Failure

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.

Detailed description

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

Interventions

DEVICEHeartlogic Diagnostic Tool Threshold Change

Heart Logic threshold set to 10 (from 16)

DEVICEHeartlogic Diagnostic Tool Unchanged Threshold

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Post market, randomized, multicenter trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hospitalizations	365 Days	Number of Hospitalizations

Secondary

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

Countries

United States

Contacts

CONTACTRobert Pickett, MD

robert.pickett@ascension.org615-329-5144

CONTACTSaint Thomas Heart at Saint Thomas Midtown

615-329-5144

PRINCIPAL_INVESTIGATORRobert Pickett, MD

Ascension Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026