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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Binita Shah, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02073617
First received: February 19, 2014
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Aortic Stenosis
Radiation: Real-time 3-dimensional DynaCT

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 23
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be more than 18 years of age with a plan to undergo TAVR.

Exclusion Criteria:

  • Subjects will be excluded if they meet one of the following criteria:

    1. estimated glomerular filtration rate <40 mL/min/1.73m2;
    2. highly irregular heart rates, frequent extra systoles, additional extra pulsations, not in sinus heart rhythm;
    3. allergy to contrast media;
    4. pregnant; or
    5. Unable to consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073617

Contacts
Contact: Binita Shah, MD, MS 212-263-4235 binita.shah@nyumc.org

Locations
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Binita Shah, MD, MS    212-263-4235    binita.shah@nyumc.org   
Principal Investigator: Binita Shah, MD, MS         
Sponsors and Collaborators
Binita Shah
Investigators
Principal Investigator: Binita Shah, MD, MS New York University School of Medicine
  More Information

No publications provided

Responsible Party: Binita Shah, MD, MS Interventional Cardiology, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02073617     History of Changes
Other Study ID Numbers: S13-00804
Study First Received: February 19, 2014
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
DynaCT
Aortic valve and root measurements
TAVR

Additional relevant MeSH terms:
Aortic Valve Stenosis
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Vascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on November 25, 2014