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

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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Surgery in Patients With Native Aortic Valve Stenosis Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis Study to Improve Outcomes in Aortic Stenosis Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) Severe Aortic Stenosis in Patients Referred for Valve Surgery Frailty and Mortality in Older Old With Severe Aortic Stenosis Myocardial Efficiency of the Left Ventricle in Asymptomatic Patients With Aortic Valve Stenosis – a Prognostic Marker and a Target for Intervention? PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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Brief Title

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

Official Title

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

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.
    

Detailed Description

      Calcific or degenerative aortic valve disease is one of the most common valvular diseases
      among the elderly and, with life expectancy continuing to increase, a major source of burden
      on current healthcare. Although patients with aortic stenosis (AS) can remain asymptomatic
      for a prolonged period, they do eventually develop symptoms, including angina, exertional
      syncope and heart failure, which is associated with a 5-year, 3-year, and 1-year,
      respectively, 50% mortality. The American College of Cardiology/American Heart Association
      guidelines place symptomatic severe AS as a class I indication for aortic valve replacement.
      Currently, surgical replacement of the aortic valve is the standard of care. However, with
      the recently approved Edwards-Sapient 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.

      Currently, patients selected for TAVR undergo an EKG-gated cardiac Multislice CTA to evaluate
      aortic valve anatomy and aortic root dimensions for device sizing. Patients also undergo
      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. Contrast-induced
      nephropathy can, in turn, lead to dialysis and/or increased mortality.

      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). DynaCT conducts
      fully automatic aortic root segmentation and overlays 3-dimensional structures onto
      2-dimensional fluoroscopy in a few seconds (~5 seconds, 60 frames/second rotational
      angiography). The software automatically recognizes and represents the aortic root, detects
      and indicates coronary ostia and lowest cusp points of aortic valve (nadir points), and
      reconstructs commissure lines of aortic valve. Due to cardiac motion, 3-dimensional images
      without motion correction or cardiac gating will look blurred. Therefore, DynaCT
      reconstruction motion correction software will be used. The DynaCT motion correction software
      is a new algorithm that will correct for this motion and apply it during reconstruction-
      allowing the user to spin without using rapid pacing. However, first, a comparison of aortic
      valve and root measurements using CTA and DynaCT must be made to affirm the accuracy of
      DynaCT vs the CTA gold standard.

      Study Design This is a pilot study evaluating patients undergoing TAVR at the New York
      University (NYU) Langone Medical Center. Patients will undergo the standard CTA protocol and
      invasive coronary angiography performed as part of the pre-operative assessment for TAVR.
      However, 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 after the study has
      reached its target recruitment. Based on these measurements, a trained interventional
      cardiologist will select the appropriate TAVR size in a similarly blinded fashion after the
      study has reached its target recruitment (i.e. the data collected using DynaCT will not be
      used in the clinical decision making process). Data will be compared from both modalities
      using appropriate tests of reproducibility and correlation.

      Study Technique CTA will be performed per standard methods as part of standard pre-TAVR
      evaluation.

      Coronary angiography will be performed via femoral artery access (minimum 6Fr) as per
      standard pre-TAVR evaluation. 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 was considered as alternative.

      As per standard care, intravenous access will be obtained and participants will be hydrated
      during the CTA, coronary angiography, and dynaCT procedures.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 TAVR size

Condition

Coronary Artery Disease

Intervention

Real-time 3-dimensional DynaCT

Study Arms / Comparison Groups

 Real-time 3-dimensional DynaCT
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

25

Start Date

January 6, 2014

Completion Date

June 13, 2017

Primary Completion Date

June 22, 2016

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Binita Shah, MD, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02073617

Organization ID

13-00804


Responsible Party

Sponsor

Study Sponsor

NYU Langone Health


Study Sponsor

Binita Shah, MD, MS, Principal Investigator, NYU Langone Health


Verification Date

July 2017