Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Aortic Stenosis
In brief
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.
Key facts
- Study ID
- NCT02073617
- Run by
- NYU Langone Health
- People needed
- 25
- Starts
- 2014-01-06
- Expected to finish
- 2017-06-13
- Last updated by the study team
- 2017-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must be more than 18 years of age with a plan to undergo TAVR.
You may not qualify if…
- Subjects will be excluded if they meet one of the following criteria:
- estimated glomerular filtration rate <40 mL/min/1.73m2;
- highly irregular heart rates, frequent extra systoles, additional extra pulsations, not in sinus heart rhythm;
- allergy to contrast media;
- pregnant; or
- Unable to consent.
Where it is running
- NYU Langone Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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