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This multi-center, observational study evaluates the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization. The study compares CPS measurements to invasive measurements to assess agreement and potential clinical utility.
The study will enroll adults undergoing right heart catheterization as part of their clinical care. A single CPS measurement will be performed before the scheduled procedure. Data from both CPS and catheterization measurements will be analyzed to assess agreement. No investigational treatment or additional follow-up visits are required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPS Measurement Group | Participants undergoing clinically indicated right heart catheterization will receive a single, non-invasive measurement using the Cardiac Performance System (CPS) before their scheduled procedure. The study aims to compare CPS results with standard invasive hemodynamic measurements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Performance System (CPS) | Device | CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Performance System electronic data for Pulmonary Pressure | Cardiac function metric measurement including Pulmonary Pressure measured in mmHg | Single measurement prior to right heart catheterization |
| Pulmonary artery catheter electronic data for Pulmonary Pressure | Cardiac function metric measurement including Pulmonary Pressure measured in mmHg | During right heart catheterization procedure |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients aged 18 years and older who are scheduled to undergo clinically indicated right heart catheterization as part of their standard medical care. Participants will represent a diverse range of individuals with conditions requiring invasive hemodynamic assessment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital Heart Center | Recruiting | Huntsville | Alabama | 35801 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Endeavor Health | Recruiting | Evanston | Illinois | 60201 | United States |
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| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Jersey Shore University Medical Center | Recruiting | Neptune City | New Jersey | 07753 | United States |
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| Columbia University Irving Medical Center / NewYork-Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
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| The Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| University of Pennsylvania - Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital | Recruiting | Germantown | Tennessee | 38138 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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