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

NCT07699874 | Active Not Recruiting FDA Device

• 1 other identifier: Emergency Departement
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Heart Failure Acute; Telemonitoring

Keywords

heart failure, acute decompensation, telemedicine, telemonitoring

Outcome Measures

Primary Outcomes (1)

• Readmission

  Hospital readmission and death after ED discharge. Factors associated with hospital readmission and death will be determined.

  30 days

Interventions

ECG Monitoting DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with HF decompensation who will be discharged from the emergency department of Fattouma Bourguiba University Hospital (Monastir, Tunisia) and emergency department of Sahloul University Hospital following HF decompensation.

Sponsors & Collaborators

• University of Monastir: lead
• Vivalink: collaborator

Study Sites (1)

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)