Congestive Heart Failure ChronicHeartlogic ISRNCT07412626
Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)
A study testing Heartlogic Diagnostic Tool Threshold Change and Heartlogic Diagnostic Tool Unchanged Threshold in people with Congestive Heart Failure Chronic and Low Ejection Fraction, run by Robert Pickett at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure Chronic, Low Ejection Fraction
- What is being tested?
- Heartlogic Diagnostic Tool Threshold Change and Heartlogic Diagnostic Tool Unchanged Threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saint Thomas Heart at Saint Thomas Midtown contact
United States2 sites
Ascension St. Vincent Medical Group
Indianapolis, Indiana, 46260
Jasen Gilge, MD, 317-338-6666, Jasen.gilge@ascension.org
Ascension St. Vincent Medical Group, 317-338-6666
Saint Thomas Heart at Saint Thomas Midtown
Nashville, Tennessee, 37203
Robert Pickett, MD, 615-329-5144, robert.pickett@ascension.org
Saint Thomas Heart at Saint Thomas Midtown, 615-329-5144
About this study
Official title: 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.
Read the detailed description
Investigator-sponsored post-market, randomized, multicenter trial evaluating the HeartLogic diagnostic in optimizing GDMT in patients with chronically low EF
- Being tested
- Heartlogic Diagnostic Tool Threshold Change, Heartlogic Diagnostic Tool Unchanged Threshold
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartlogic Diagnostic Tool Threshold ChangeDevice
Heart Logic threshold set to 10 (from 16)
Heartlogic Diagnostic Tool Unchanged ThresholdDevice
Heartlogic Threshold to remain at 16, which is the normal limit.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Arm | Active comparator | Heart Logic threshold set to 10 (from 16) will trigger a treatment algorithm, which includes up titration of GDMT Receives: 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. Receives: Device: Heartlogic Diagnostic Tool Unchanged Threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalizations
Number of Hospitalizations
Measured: 365 Days
Secondary outcomes (2)
Number of ICD Shocks
Number of ICD shocks due to VT, VF and changes to AFib burden
Measured: 365 Days
nt-ProBNP
Changes to nt-proBNP
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Post market, randomized, multicenter trial
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Pickett
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Ascension Health
- Responsible party
- Sponsor-investigator, Robert Pickett, Ascension Health
- Investigators
- Robert Pickett, MD, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412626
- Sponsor's protocol ID
- RTN20250021
- Acronym
- Heartlogic ISR
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartLogic Optimization of CHF Medications in Chronic Low EF Population: A Follow-on Study
- ClinicalTrials.gov ID
- NCT07412626
- Acronym / sponsor ID
- Heartlogic ISR / RTN20250021
- Keywords
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Robert PickettIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, Ascension Health
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Post market, randomized, multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Arm | Active comparator | Device: Heartlogic Diagnostic Tool Threshold ChangeHeart Logic threshold set to 10 (from 16) will trigger a treatment algorithm, which includes up titration of GDMT |
| Control Arm | Placebo comparator | Device: Heartlogic Diagnostic Tool Unchanged ThresholdHeart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heartlogic Diagnostic Tool Threshold ChangeHeart Logic threshold set to 10 (from 16) | Device | Active Treatment Arm |
| Heartlogic Diagnostic Tool Unchanged ThresholdHeartlogic Threshold to remain at 16, which is the normal limit. | Device | Control Arm |
Primary outcome
Hospitalizations
Time frame: 365 Days
Number of Hospitalizations
2 secondary outcomes
Number of ICD Shocks
Time frame: 365 Days
nt-ProBNP
Time frame: 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saint Thomas Heart at Saint Thomas Midtown contact
Robert Pickett, MD principal investigator
Ascension Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heartlogic Diagnostic Tool Threshold Change and Heartlogic Diagnostic Tool Unchanged Threshold in people with Congestive Heart Failure Chronic and Low Ejection Fraction, run by Robert Pickett at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Pickett, MD (615-329-5144, robert.pickett@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalizations (time frame: 365 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.