HeartLogic™ in Patients With Heart Failure. (NCT07544771) | Clinical Trial Compass
RecruitingNot Applicable
HeartLogic™ in Patients With Heart Failure.
France578 participantsStarted 2026-04-29
Plain-language summary
This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device. The primary objective is to determine whether this strategy reduces, at 12 months, the proportion of patients with death, unscheduled hospitalization for heart failure, or deterioration in quality of life. Secondary objectives include assessment of hospitalization, mortality, quality of life, safety, and cost-effectiveness.
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
. Patients aged ≥18 years old;
. Patients implanted with a cardiac defibrillator for less than 6 months, with or without resynchronization, enabling the HeartLogic™ algorithm;
. Patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with NT-proBNP blood concentration ≥450 ng/L);
. Patients with New York Heart Association Class II or III HF;
. Patient able to comply with the protocol, including Latitude™ transmissions (including adequate connectivity), and study visits.
. Patients with compulsory health insurance
Exclusion criteria
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
1
Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life.
. Patients not consenting and non-compliant with remote care directions.
. Patients with invasive remote HF monitoring device (such as CardioMems);
. Patients with a concomitant HF device other than cardiac resynchronization, such as a ventricular assist devices or cardiac contractility modulation devices;
. Patients on heart transplant list, or patients with a heart transplant;
. Patients with a glomerular filtration rate \<30 ml/min/m2;
. Participation to a concomitant study evaluating management of HF decompensation, or diuretic titration.
. Patients enable to consent.
. Patients receiving State Medical Aid (Aide Médicale d'Etat).