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This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to Right Heart Cath (RHC). The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by CorVista Health (formerly Analytics 4 Life).
Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals. Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and right heart catheterization. In this study, resting phase signals will be acquired in subjects prior to Right Heart Catheterization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Subjects (PSR) | Other | Patients who meet the study's entrance criteria and provide written informed consent, will undergo signal acquisition prior to their scheduled right heart catheterization (RHC) on the day of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorVista Capture | Device | The CorVista System is a medical device system that is being developed to collect phase signals from patients to support the development and testing of machine learned algorithms developed by CorVista Health. Data collected with the CorVista System during this study will not be used to guide treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Signal Recorder Procedure | Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization. | 7 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horace R Gillins, BS CCRP | CorVista Health | Study Director |
| William E Sanders, Jr, MD JD LLM MBA FHRS | CorVista Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC-MHS (UCHealth Memorial) | Colorado Springs | Colorado | 80909 | United States | ||
| University of Colorado-MHS (UCHealth Memorial) |
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Repository study designed to collect signals using the CorVista Capture in subjects scheduled for Right Heart Catheterization
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|
| Colorado Springs |
| Colorado |
| 80920 |
| United States |
| WellStar Research Institute | Marietta | Georgia | 30060 | United States |
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
| Cardiology Associates Research, LLC | Tupelo | Mississippi | 38801 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| The Rochester General Hospital | Rochester | New York | 14621 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| Allegheny Health Network Research Institute | Natrona Heights | Pennsylvania | 15065 | United States |
| Allegheny Health Network Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| AnMed Health | Anderson | South Carolina | 29621 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Lexington Cardiology / Lexington Medical Heart and Vascular Center | Lexington | South Carolina | 29169 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Sentara Hospitals and Sentara Medical Group | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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