NCT07544771 HeartLogic™ in Patients With Heart Failure.
| NCT ID | NCT07544771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poitiers University Hospital |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 578 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2028-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 578 participants in total. It began in 2026-04-29 with a primary completion date of 2028-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07544771 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07544771 currently recruiting?
Yes, NCT07544771 is actively recruiting participants. Contact the research team at celine.deletage@chu-poitiers.fr for enrollment information.
Where is the NCT07544771 trial being conducted?
This trial is being conducted at Amiens, France, Brest, France, Caen, France, Grenoble, France and 11 additional locations.
Who is sponsoring the NCT07544771 clinical trial?
NCT07544771 is sponsored by Poitiers University Hospital. The trial plans to enroll 578 participants.
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