Non-invasive Pulmonary Artery Prediction

Heart Failure Clinical Trial

— ADOPTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622695
• Other study ID #: ADOPTS_GOODSAM
• Status: Recruiting
• Start date: October 30, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2022
• Source: Silverleaf Medical Sciences INC
• Contact: Jianwei Zheng, Ph.D.
• Phone: 9493298388
• Email: zheng[@]slmedsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	PIH Good Samaritan Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Silverleaf Medical Sciences INC	PIH Health Good Samaritan Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zheng J, Abudayyeh I, Mladenov G, Struppa D, Fu G, Chu H, Rakovski C. An artificial intelligence-based noninvasive solution to estimate pulmonary artery pressure. Front Cardiovasc Med. 2022 Aug 24;9:855356. doi: 10.3389/fcvm.2022.855356. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of pulmonary artery pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm	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 Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes.
Primary	The correlation of pulmonary artery wedge pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm	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.	the Swan-Ganz catheter obtains wedge pressures first for a minimum of 20 seconds (20-30 seconds).