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

NCT02073617 | Completed DMC

• 1 other identifier: 13-00804
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Aortic Stenosis

Keywords

DynaCT; Aortic valve and root measurements; TAVR

Outcome Measures

Primary Outcomes (1)

• Correlation of aortic annulus measurement measured on invasive 3D dyna CT (experimental) and on non-invasive CT scan (standard of care)

  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 and non-invasive CT.

  1 day

Secondary Outcomes (1)

• TAVR size

  1 day

Study Arms (1)

Real-time 3-dimensional DynaCT

EXPERIMENTAL

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

Interventions

Real-time 3-dimensional DynaCT RADIATION

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. Intravenous delivery of contrast as alternative.

Real-time 3-dimensional DynaCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Binita Shah, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 27, 2014
• Study Start: January 6, 2014
• Primary Completion: June 22, 2016
• Study Completion: June 13, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

US (1)