HeartLogicâ„¢ in Patients With Heart Failure. (NCT07544771) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
HeartLogicâ„¢ in Patients With Heart Failure.
France578 participantsStarted 2026-04-15
Plain-language summary
This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogicâ„¢ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogicâ„¢-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 range18 Years
SexALL
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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
✕. 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;
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.