Heart Diseases Clinical Trial
Official title:
Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study
Verified date | May 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)
Status | Completed |
Enrollment | 79 |
Est. completion date | January 2, 2024 |
Est. primary completion date | January 2, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: • Patients over 18 scheduled for a standard echocardiogram Exclusion Criteria: - Patients with heart transplant history - Patients with a Implanted Left Ventricular Assist Device (LVAD) - Patients who have surgical scars, wounds, or bandages at the site of sensor placement - Inadequate TTE imaging windows in left lateral position - Otherwise deemed by the investigator as medically unfit to participate - Chest deformities including, for example, pectus excavatum |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Montefiore Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Stephen Esper | Sensydia Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Performance System electronic data for Ejection Fraction | Cardiac function measurement including left ventricle ejection fraction to report in percentage | 60 minutes during Echocardiography procedure | |
Primary | Cardiac Performance System electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m | 60 minutes during Echocardiography procedure | |
Primary | Cardiac Performance System electronic data for Pulmonary Artery Pressure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. | 60 minutes during Echocardiography procedure | |
Primary | Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg | 60 minutes during Echocardiography procedure | |
Primary | Echocardiography electronic data for Ejection Fraction | Cardiac function measurement including left ventricle ejection fraction to report in percentage | 60 minutes during Echocardiography procedure | |
Primary | Echocardiography electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m | 60 minutes during Echocardiography procedure | |
Primary | Echocardiography electronic data for Pulmonary Artery Pressure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. | 60 minutes during Echocardiography procedure | |
Primary | Echocardiography electronic data for Pulmonary Artery Wedge Pressure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg | 60 minutes during Echocardiography procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04624412 -
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
|
N/A | |
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Recruiting |
NCT04561908 -
Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access
|
N/A | |
Active, not recruiting |
NCT06190743 -
Perception of Cardiovascular Risk
|
||
Completed |
NCT04580095 -
Artificial Intelligence for Improved Echocardiography
|
N/A | |
Completed |
NCT04562636 -
Evaluating a Messaging Campaign in the United States
|
N/A | |
Recruiting |
NCT03277365 -
MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
|
N/A | |
Active, not recruiting |
NCT05553106 -
Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
|
||
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Enrolling by invitation |
NCT03314818 -
Natural History of Carotid Plaque as Determined by 3D Ultrasound
|
N/A | |
Withdrawn |
NCT03289104 -
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
|
N/A | |
Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
Completed |
NCT02046902 -
Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
|
||
Completed |
NCT01909349 -
Web-based Aftercare Intervention for Cardiac Patients
|
N/A | |
Completed |
NCT01944254 -
The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients
|
N/A | |
Recruiting |
NCT01457586 -
Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
|
Phase 4 | |
Recruiting |
NCT01541163 -
Heart and Ischemic STrOke Relationship studY
|
N/A | |
Recruiting |
NCT01207167 -
Mediators of Atherosclerosis in South Asians Living in America
|
||
Terminated |
NCT00968383 -
Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
|
N/A |