NCT02073617

Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography

Completed NA Last updated 18 July 2017

What this trial tests

NA trial testing Real-time 3-dimensional DynaCT in Coronary Artery Disease in 25 participants. Completed in 13 June 2017.

Timeline

6 January 2014

Primary endpoint
22 June 2016

13 June 2017

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	6 January 2014
Primary completion	22 June 2016
Estimated completion	13 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Real-time 3-dimensional DynaCT

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Aortic Stenosis — all drugs for Aortic Stenosis →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease or Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.