Non-invasive Pulmonary Artery Prediction

NCT05622695 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2022-11-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • PIH Health Good Samaritan Hospital

    collaborator UNKNOWN
  • Silverleaf Medical Sciences INC

    lead INDUSTRY

Principal Investigators

  • Jianwei Zheng, Ph.D. · Silverleaf Medical Sciences

  • Ihab Alomari, Dr. · PIH Good Samaritan Hospital

  • Islam Abudayyeh, Dr. · Loma Linda University Health

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-30
Primary Completion
2023-04-30
Completion
2023-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT05622695 on ClinicalTrials.gov