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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 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-07-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Vivalink

    collaborator INDUSTRY

  • University of Monastir

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699874 on ClinicalTrials.gov