Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Heart Failure Clinical Trial

Official title: Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.

Clinical Trial Description

Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure.

The research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT01377350
• Study type: Interventional
• Source: Rambam Health Care Campus
• Contact: Shmuel rispler, MD PhD
• Phone: 972-4-8542180
• Email: s_rispler@rambam.health.gov.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2011
• Completion date: December 2012