Not Yet RecruitingNot Applicable

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

United States135 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hospitalizations

Timeframe: 365 Days

Trial details

NCT IDNCT07412626

SponsorRobert Pickett

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Robert Pickett, MD

615-329-5144 robert.pickett@ascension.org

View on ClinicalTrials.gov More Congestive Heart Failure Chronic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.