An observational study in Heart Failure and Pulmonary Arterial Hypertension, sponsored by Silverleaf Medical Sciences INC. Status unknown at 1 site in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-11-21.
Sponsored by Silverleaf Medical Sciences INC · Observational
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.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's planned enrollment of 25 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Silverleaf Medical Sciences INC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with heart failure conditions.
Exclusion Criteria:
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.
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.
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.
Time frame: the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes.
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.
Time frame: the Swan-Ganz catheter obtains wedge pressures first for a minimum of 20 seconds (20-30 seconds).
Plan to share: No
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
Silverleaf Medical Sciences INC