Evaluation of the HeartLogic Diagnostic in Optimizing Gui... | NCT07412626

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

NCT07412626

Sponsor

Robert Pickett

Status

Not yet recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

135Estimated

Phase

Not Applicable

Conditions

Congestive Heart Failure Chronic
Low Ejection Fraction

Interventions

Heartlogic Diagnostic Tool Threshold Change
Heartlogic Diagnostic Tool Unchanged Threshold

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Feb 13, 2026

First Posted Date

Feb 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 17, 2026Actual

Name	Class
Boston Scientific Corporation	INDUSTRY
Ascension Health	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Treatment Arm	Active Comparator	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
Control Arm	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heartlogic Diagnostic Tool Threshold Change	Device	Heart Logic threshold set to 10 (from 16)	Active Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalizations	Number of Hospitalizations	365 Days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
EF \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert Pickett, MD	Contact	615-329-5144		robert.pickett@ascension.org
Saint Thomas Heart at Saint Thomas Midtown	Contact	615-329-5144

Overall Officials

Name	Affiliation	Role
Robert Pickett, MD	Ascension Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ascension St. Vincent Medical Group		Indianapolis	Indiana	46260	United States

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases