NCT05622695

Non-invasive Pulmonary Artery Prediction

Study to Determine if Novel Wearable Monitoring System and Machine-Learning Algorithm Can Model Continuous Pulmonary Artery Pressure Recordings in Human Subjects

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Silverleaf Medical Sciences INC · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Cardiac remote monitoring devices have expanded our ability to track physiological changes used in the diagnosis and management of patients with cardiac disease. Implantable remote monitoring technologies have been shown to predict heart failure events, and guide therapy to reduce heart failure hospitalizations. The CardioMEMs System, the most studied and established remote monitoring system, relies on a pulmonary artery implant for continuous PAP measurement. However, there are no commercially available wearable systems that can reproduce continuous PAP tracings. This study aims to determine if a machine-learning algorithm with data from a wearable cardiac remote-monitoring system incorporating EKG, heart sounds, and thoracic impedance can reproduce a continuous PAP tracing obtained during right heart catheterization.

Conditions

• Heart Failure
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DEVICE	catheterization	Swan-Ganz catheterization (also called right heart catheterization or pulmonary artery catheterization) is the passing of a thin tube (catheter) into the right side of the heart and the arteries leading to the lungs. It is done to monitor the heart's function and blood flow and pressures in and around the heart.

Timeline

• Start date: 2022-10-30
• Primary completion: 2023-04-30
• Completion: 2023-08-31
• First posted: 2022-11-21
• Last updated: 2022-11-21

Locations

1 site across 1 country: United States