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 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.
Coronary Artery Disease
Radiation: Real-time 3-dimensional DynaCT
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography|
- Correlation of aortic annulus measurement measured on invasive 3D dyna CT (experimental) and on non-invasive CT scan (standard of care) [ Time Frame: 1 day ] [ Designated as safety issue: No ]Each patient will undergo non-invasive CT scan for aortic annulus measurement (in order to choose appropriate TAVR size) as per standard of care. They will then undergo invasive dyna CT for aortic annulus measurement during their clinically-indicated invasive coronary angiogram. The primary outcome is correlation between the aortic annulus dimension measurement made on dyna CT andnon-invasive CT.
- TAVR size [ Time Frame: 1 day ] [ Designated as safety issue: No ]A trained interventional cardiologist will evaluate the measurements made from each CTA abd DynaCT image and select the appropriate TAVR size in a blinded fashion.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Real-time 3-dimensional DynaCT
Patients will undergo the standard CTA protocol and invasive coronary angiography performed as part of the pre-operative assessment for TAVR. Patients in this study will also undergo DynaCT during coronary angiography, utilizing 1 acquisition sweep and 20 to 35cc more of contrast media. Measurements of the major aortic annulus diameter, orthogonal minor aortic annulus diameter, aortic annulus perimeter, maximum ascending aorta diameter at 40mm above the annulus, sinus of Valsalva diameters, sinus of Valsalva heights, and aortic root angulation will be made using both the CTA and DynaCT protocols by a radiologist blinded to patient identity. Based on these measurements, a trained interventional cardiologist will select the appropriate TAVR size for the patient.
Radiation: Real-time 3-dimensional DynaCT
After coronary angiography is performed, a 6Fr pigtail catheter will be placed in the aorta and 40cc of 50% contrast media diluted normal saline will be delivered using standard automated injection during dynaCT cardiac image acquisition.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02073617
|Contact: Binita Shah, MD, MSemail@example.com|
|United States, New York|
|NYU Langone Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: Binita Shah, MD, MS 212-263-4235 firstname.lastname@example.org|
|Principal Investigator: Binita Shah, MD, MS|
|Principal Investigator:||Binita Shah, MD, MS||New York University School of Medicine|