NCT05641675

Non-invasive Pulmonary Artery Prediction (ADOPTS)

Feasibility 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

A proprietary machine-learning algorithm has been developed to model continuous pulmonary artery pressure (PAP), a physiologic marker of cardiopulmonary function. The algorithm was developed from PAP recordings obtained during invasive right heart catheterization. The study will evaluate whether this algorithm can perform as well when embedded into a non-invasive wearable device that records EKG, heart sounds, and thoracic impedance has yet to be established.

Detailed description

A prototype device will be supplied by Silverleaf Medical Science (Redlands, CA) to record these signals. This study will take place at Loma Linda VA, in the cardiac catheterization lab as an add-on to clinically-indicated right heart catheterizations, and under the supervision of heart failure and interventional cardiologists. The investigators will screen and enroll 20 Veterans who consent to participate in the study. Veterans who decline to consent and vulnerable populations will be excluded from the study. The investigators will obtain simultaneous recordings from the prototype device (EKG, heart sounds, and thoracic impedance) and from the PAP catheter , both at rest (5 minutes), and in response to physiological maneuvers: hand grip, passive leg raise, and Valsalva (1 minute recordings with 1-minute breaks). De-identified recordings from the prototype device will be shared with the team at Silverleaf Medical Science to derive a computed PAP. The investigators will test the hypothesis that computed PAP is no different than measured PAP. If the algorithm can produce a computed PAP with high accuracy,'\[it would be the first wearable system to non-invasively report PAP.

Conditions

• Heart Failure
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	right heart catheterization	Connect to a heart monitor to record heart rate, blood pressure and blood oxygen levels Place sterile sheets on chest and neck (or groin area) Clean the skin over the neck or groin Give local anaesthetic to numb the area (this may sting a little when it is given) Gently pass a catheter into a vein to the heart Record pressure readings from the heart chambers and lungs Give medication, depending on heart's pressure readings Remove the catheter and apply pressure where it was inserted

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-07-01
• Completion: 2023-10-01
• First posted: 2022-12-08
• Last updated: 2022-12-20

Locations

1 site across 1 country: United States