HeartLogic-guided remote heart failure follow-up for adults with an implanted HeartLogic-enabled ICD/CRT-D

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares HeartLogic-guided remote management to conventional face-to-face follow-up for adults with heart failure who recently received a HeartLogic-enabled ICD or CRT-D. The trial uses the Latitude platform to transmit alerts that may trigger a predefined management pathway, including clinician contact and potential treatment adjustments. Outcomes include death, hospitalizations for heart failure, quality of life, safety, and cost-effectiveness over 12 months. A health economic evaluation accompanies the clinical endpoints to assess overall value. The study aims to determine if proactive, alert-driven care can improve outcomes in routine practice.

Why it matters

Who can join: the full rules

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

Where it's running

• University hospital of Poitiers
  Poitiers, France Recruiting
• University hospital of Amiens
  Amiens, France Not yet recruiting
• University hospital of Brest
  Brest, France Not yet recruiting
• University hospital of Caen
  Caen, France Not yet recruiting
• University hospital of Grenoble
  Grenoble, France Not yet recruiting
• University hospital of Lille
  Lille, France Not yet recruiting

Study contacts

• Study coordinator: Céline Deletage
• Email: celine.deletage@chu-poitiers.fr
• Phone: +33549443854

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.