Non-invasive Pulmonary Artery Prediction

Recruiting

• Conditions: Heart Failure; Pulmonary Arterial Hypertension
• Interventions: Device: catheterization

• Registration Number: NCT05622695
• Lead Sponsor: Silverleaf Medical Sciences INC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-30
• Status Verified: 2022-11
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-21
• Last Update Posted: 2022-11-21
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Subjects age 18+ years
2. Undergoing a right heart cardiac catheterization or in the cardiac care unit with active monitoring using an arterial line or Swan-Ganz catheter.

Exclusion Criteria

1. Vulnerable population
2. Unable to consent for any reason
3. Unstable patient
4. Known skin reaction to latex or adhesives

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Catheterization Arm	catheterization	Participants will be limited to adults older than 18 years of age, able to consent, planned for the cardiac catheterization lab for a right heart catheterization or in the cardiac care unit with an existing arterial line or Swan-Ganz catheter actively measuring the pulmonary artery pressure on a continuous basis.

Primary Outcome Measures

Name	Time	Method
The correlation of pulmonary artery pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm	the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes.	The primary objective of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous pulmonary artery pressure obtained during right heart catheterization or data obtained from a Sawn Ganz catheter already in place in the setting of cardiac care unit admission.
The correlation of pulmonary artery wedge pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm	the Swan-Ganz catheter obtains wedge pressures first for a minimum of 20 seconds (20-30 seconds).	The second objective of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous pulmonary artery wedge pressure obtained during right heart catheterization or data obtained from a Sawn Ganz catheter already in place in the setting of cardiac care unit admission.

Trial Locations

Locations (1)

PIH Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States