Non-invasive Pulmonary Artery Prediction
Study Purpose
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 Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 20 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05622695 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Silverleaf Medical Sciences INC |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Jianwei Zheng, Ph.D.Ihab Alomari, Dr.Islam Abudayyeh, Dr. |
| Principal Investigator Affiliation | Silverleaf Medical SciencesPIH Good Samaritan HospitalLoma Linda University Health |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
| Overall Status | Recruiting |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Heart Failure, Pulmonary Arterial Hypertension |
Contact a Trial Team
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