Clinical Trial

Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure : A Pilot Study Using a New Wearable Sensor

Study acronym: TELE_HF
Active, Not Recruiting
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Summary
Heart failure (HF) is a growing global public health concern. Worldwide, the estimated prevalence of HF has increased to \>64.3 million cases. Despite improvement in outcomes with medication, HF is a leading cause of hospitalization among individuals \>65 years. Approximately 30-40% of HF patients have a history of hospitalization, and 50% are re- admitted with 1 year within their initial diagnosis of HF . In Tunisia, the current statistics (2017) show that the all-cause 1-year mortality rate among acute HF patient was 22.8%, the 1-year rate of hospitalization because of HF was 7.3%, and the 1-year incidence rates of the combined event (all-cause mortality or HF hospitalization) was 18.7%. Available literature highlighted that patient monitoring using wearable biosensors is a promising strategy to improve cardiovascular patients care and have potential to support clinical practice and improve patient outcomes . The objective of this protocol is to evaluate the feasibility and effectiveness of continuous tele- ECG monitoring in predicting hospital readmission and other clinical relevant outcome in patients with AF discharged from the emergency department (ED) after HF decompensation using a novel device "VIVALINK ECG Patch".
Trial Details
NCT Number NCT07699874
Lead Sponsor University of Monastir
Collaborators: Vivalink
Conditions Heart Failure Acute, Telemonitoring
Enrollment 50 participants
Start Date 2026-01-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-13