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NCT07699874

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

Sponsor: University of Monastir

View on ClinicalTrials.gov

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".

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-01-01

Completion Date

2027-12-31

Last Updated

2026-07-13

Healthy Volunteers

Not specified

Interventions

DEVICE

ECG Monitoting

Participants will be provided with a chest-worn biosensor ECG patch (Vivalink's multi-vital wearable ECG monitor, VIVALINK California, USA) , which collects real-time continuous ECG and heart rate variability. This multi-function cardiac patch can live stream multiple parameters to a mobile device or the cloud. It is reusable, rechargeable. The related platform offers both raw vital and analysis data: (1) Raw vital data records the ECG, heart rate, respiratory rate, and acceleration with timestamps, (2) Analysis data: arrhythmia detection. Continuous monitoring will be insured for 30 days after patient discharge to identify patients potentially at risk of hospital readmission. The daily statistics include mean heart rate, mean respiratory rate, acceleration index, number of premature ventricular contractions and ventricular arrythmia and other potential arrhythmias.

Locations (1)

Fattouma Bourguiba University Hospital

Monastir, Tunisia