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NCT01557582 · ClinicalTrials.gov registry record · NA
Assessmet of Patients With PAH Right Ventricular Volume
A NA study, sponsored by VentriPoint Diagnostics.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT01557582 is a NA study that has completed, run by VentriPoint Diagnostics. The registered enrollment target is 103 participants.
The verdict
NCT01557582, a NA study, has completed, sponsored by VentriPoint Diagnostics.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Ventripoint Medical System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01557582
The ClinicalTrials.gov registry entry for NCT01557582 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VentriPoint Diagnostics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ventripoint Medical System is the first listed.
NCT01557582 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01557582 about?
NCT01557582 is a clinical study titled "Assessmet of Patients With PAH Right Ventricular Volume". 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 positi...
What is the current status of trial NCT01557582?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2012-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01557582?
The interventions under investigation include: Ventripoint Medical System (DEVICE).
Who is sponsoring clinical trial NCT01557582?
This trial is sponsored by VentriPoint Diagnostics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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