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Набира участници NCT06870591

Pivotal Study for the Cardiac Performance System (CPS)

Заболявания: Cardiovascular Diseases

Спонсор: Sensydia Corporation

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
Inclusion Criteria: * Adults aged 18 years or older * Scheduled for clinically indicated right heart catheterization * Ability to provide informed consent Exclusion Criteria: * Heart transplant recipients * Patients with a left ventricular assist device (LVAD) * Presence of external devices (e.g., Holter monitors) or surgical scars/wounds that interfere with CPS measurements * Measurement concerns related to data reliability or quality
Интервенции
Cardiac Performance System (CPS)
DEVICE
Места на провеждане 10
САЩ (10)
Medical University of South Carolina
Charleston , South Carolina
Principal Investigator
The Ohio State University Medical Center
Columbus , Ohio
Endeavor Health
Evanston , Illinois
The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital
Germantown , Tennessee
Hackensack University Medical Center
Hackensack , New Jersey
Principal Investigator
Baylor College of Medicine
Houston , Texas
Huntsville Hospital Heart Center
Huntsville , Alabama
Jersey Shore University Medical Center
Neptune City , New Jersey
Principal Investigator
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York , New York
University of Pennsylvania - Penn Presbyterian Medical Center
Philadelphia , Pennsylvania
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.04.2025
Крайна дата
30.05.2026
Регистрационен номер
NCT06870591
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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