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HeartLogic™ in Patients With Heart Failure.

RecruitingNAAges 18 Years - anyAllPoitiers University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients aged ≥18 years old; 2. Patients implanted with a cardiac defibrillator for less than 6 months, with or without resynchronization, enabling the HeartLogic™ algorithm; 3. 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); 4. Patients with New York Heart Association Class II or III HF; 5. Patient able to comply with the protocol, including Latitude™ transmissions (including adequate connectivity), and study visits. 6. Patients with compulsory health insurance Exclusion Criteria: 1. Patients not consenting and non-compliant with remote care directions. 2. Patients with invasive remote HF monitoring device (such as CardioMems); 3. Patients with a concomitant HF device other than cardiac resynchronization, such as a ventricular assist devices or cardiac contractility modulation devices; 4. Patients on heart transplant list, or patients with a heart transplant; 5. Patients with a glomerular filtration rate \<30 ml/min/m2; 6. Participation to a concomitant study evaluating management of HF decompensation, or diuretic titration. 7. Patients enable to consent. 8. Patients receiving State Medical Aid (Aide Médicale d'Etat). 9. Pregnant or breastfeeding women. 10. Persons benefiting from a reinforced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations
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What it tests

  • Alert-guided remote follow-up
  • Traditional follow up
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Where

15 sites
University hospital of Amiens
Amiens, France
University hospital of Brest
Brest, France
University hospital of Caen
Caen, France
University hospital of Grenoble
Grenoble, France
University hospital of Lille
Lille, France
La Timone University hospital
Marseille, France
Hopital du Confluent
Nantes, France
University hospital of Nantes
Nantes, France

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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