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The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial will be defined as positive if the mean VMS-cMRI percent difference is <10% and >-10% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.
The objective of this study is: The comparison of the VMS and MRI values for EDV, ESV, and EF using 75 subjects.
Secondary objectives are:
The determination of VMS inter-observer and intra-observer variability of these quantities using 30 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right ventrical volumn comparison | Other | Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventripoint Medical System | Device | The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required. Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images. |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Mean (Std Err) for % Difference Between VMS and MRI. | % Difference was measured for right ventricular EDV, ESV and EF. | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-Observer Variability | A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies. | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. |
| Intra-Observer Variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Barst, MD | Scientific Advisory Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Brigham and Women's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Right Ventrical Volume Comparison | Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension. Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required. Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic information was not available for 2 patients. One subject failed to disclose metal in his abdomen and the other was due to user error.
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| ID | Title | Description |
|---|---|---|
| BG000 | Right Ventrical Volume Comparison | Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension. Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required. Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observed Mean (Std Err) for % Difference Between VMS and MRI. | % Difference was measured for right ventricular EDV, ESV and EF. | Only evaluable participants were analyzed | Posted | Mean | Standard Error | Percent difference | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. |
|
Adverse events were only collected during imaging.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Right Ventrical Volume Comparison | Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension. Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required. Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jim bodtke, Vice President Clinical Affairs and Development | VentriPoint, Inc. | 206-283-0221 | jbodtke@ventripoint.com |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)
| VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Baylor | Houston | Texas | 77030 | United States |
| Toronto General Hospital | Tononto | Ontario | M5G-2C4 | Canada |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| WHO Functional Health Class | The World Health Organization (WHO) has developed a system to help doctors determine how limited a patient is in their ability to do the activities of daily living. In general, patients with more severe PH tend to have a higher functional class. Class I: pulmonary hypertension without resulting limitation of physical activity; Class II: slight limitation of physical activity; Class III: marked limitation of physical activity. | Number | participants |
|
| Etiology | Number | participants |
|
|
|
|
| Secondary | Inter-Observer Variability | A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies. | All evaluable subjects. | Posted | Mean | Standard Deviation | Percent difference | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. |
|
|
|
| Secondary | Intra-Observer Variability | Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1) | Posted | Mean | Standard Deviation | Percent difference | VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour. |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
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| Title | Measurements |
|---|---|
|
| ESV Observer 2 vs. 1 |
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| ESV Observer 3 vs. 1 |
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| ESV Observer 3 vs. 2 |
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| EF Observer 2 vs. 1 |
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| EF Observer 3 vs. 1 |
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| EF Observer 3 vs. 2 |
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| Title | Measurements |
|---|---|
|
| ESV Observer 1 |
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| ESV Observer 2 |
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| ESV Observer 3 |
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| EF Observer 1 |
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| EF Observer 2 |
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| EF Observer 3 |
|