HeartLogic™ in Patients With Heart Failure.
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Alert-guided remote follow-up
- Traditional follow up
Treatment groups
578 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov