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NCT02073617 · ClinicalTrials.gov registry record · NA
Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT02073617 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 25 participants.
The verdict
NCT02073617, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The American College of Cardiology/American Heart Association guidelines place symptomatic severe Aortic Stenosis as a class I indication for aortic valve replacement. With the recently approved Edwards-Sapien TAVR device and the ongoing investigations using the CoreValve TAVR device, patients ineligible or at high risk for open-heart surgery are now eligible to undergo TAVR. Patients selected for TAVR undergo an EKG-gated cardiac Multislice CTA to evaluate aortic valve anatomy and aortic root dimensions for device sizing, as well as coronary angiography to define coronary anatomy. Both tests utilize contrast media to visualize anatomy, which may result in contrast-induced nephropathy in anywhere from 7.5% to more than 50% of patients depending on associated clinical risk factors. There is a need to consolidate this pre-operative testing whenever possible, and with real-time 3-dimensional visualization of aortic valve and root anatomy using DynaCT cardiac acquisition in the cath lab angiography suite during the coronary angiography, there may be a benefit with reduced contrast load (20 to 35cc for DynaCT, 100cc for CTA). We would like to make a comparison of aortic valve and root measurements using CTA and DynaCT to affirm the accuracy of DynaCT vs the CTA gold standard.
Interventions
- RADIATION Real-time 3-dimensional DynaCT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-01-06 |
| Est. Completion | 2017-06-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02073617
The ClinicalTrials.gov registry entry for NCT02073617 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Real-time 3-dimensional DynaCT is the first listed.
NCT02073617 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02073617 about?
NCT02073617 is a clinical study titled "Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography". The American College of Cardiology/American Heart Association guidelines place symptomatic severe Aortic Stenosis as a class I indication for aortic valve replacement. With the recently approved Edwards-Sapien TAVR device and the ongoing investigations using the CoreValve TAVR device, patients ineli...
What is the current status of trial NCT02073617?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2014-01-06. Estimated completion is 2017-06-13.
What interventions are being tested in trial NCT02073617?
The interventions under investigation include: Real-time 3-dimensional DynaCT (RADIATION).
Who is sponsoring clinical trial NCT02073617?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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