Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TEE/Angio Fusion Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737969
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a pilot study of patients undergoing structural heart disease procedures that utilize TEE and fluoroscopic guidance at the New York University (NYU) Langone Medical Center. Patients in this study will undergo their procedure utilizing the TEE/Angio fusion software prototype. This protocol is primarily intended to ascertain the potential utility of the software prototype in the study population and to provide data and feedback to improve the workflow and algorithms of the prototype. As such, a primary outcome variable and statistical analysis plan have not been identified. However, procedural time, measures of radiation exposure (dose area product, total radiation dose, fluoroscopy time), degree of residual valvular regurgitation or paravalvular regurgitation as applicable, and complications will be recorded.

Condition or disease Intervention/treatment Phase
Structural Heart Disease Device: Transesophageal Echocardiography/angiography (TEE/Angio) Not Applicable

Detailed Description:

This study is for patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes TEE and fluoroscopic guidance at the NYU Langone Medical Center. It will evaluate the utility and workflow of the transesophageal echocardiography/angiography (TEE/Angio) fusion software prototype to provide visualization of anatomic landmarks and guidance during structural heart disease procedures.

The purpose of this study is to evaluate software (TEE/Angio fusion) that merges images from two standard procedures (ultrasound and x-ray) used to look at the heart during a procedure for structural heart disease. Typically, these 2-dimensional images are viewed separately, requiring the operator to mentally merge the two images together while deciding if he/she is in the correct location for the treatment strategy. TEE/Angio fusion is designed to make a single 3-dimensional image of the heart in real-time.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Transesophageal Echocardiography/Angiography Fusion Software Prototype for Structural Heart Disease Procedures
Study Start Date : April 2016
Estimated Primary Completion Date : August 21, 2019
Estimated Study Completion Date : August 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: TEE/Angio fusion software Device: Transesophageal Echocardiography/angiography (TEE/Angio)

The TEE probe will be inserted into the patient's esophagus, after anesthetic induction or conscious sedation is administered, and removed after the completion of the procedure. Once the TEE probe is placed, the interventional cardiologist will acquire 2 fluoroscopic images with the TEE probe. These images will be used to co-register the ultrasound and fluoroscopy systems. As part of routine care, TEE and fluoroscopy images will be acquired throughout the procedure for clinical purposes. As new fluoroscopy images are acquired, the prototype software will automatically track the location of the TEE probe. When the echocardiographer has an image of a cardiac structure of interest, he may use the prototype software to place landmarks.

The echocardiographer may then press a button to have the landmarks displayed on the fluoroscopy image that is only visible on an assist monitor and will not interfere with the standard fluoroscopy imaging monitor.





Primary Outcome Measures :
  1. Procedural Time` [ Time Frame: One day ]
  2. Dose Area Product of Radiation Exposure [ Time Frame: One day ]
    Once the TEE probe is placed, the interventional cardiologist will acquire 2 fluoroscopic images with the 'tee probe in view, at least 30 degrees apart. These 2 images will be used to co-register the ultrasound and fluoroscopy systems. The document entitled, "NSR_EchoXrayFusion", this adds a negligible amount of radiation exposure (0.0006%).

  3. Degree of residual valvular or paravalvular regurgitation [ Time Frame: One day ]
  4. Total Radiation Dose [ Time Frame: One Day ]
  5. Fluoroscopy Time [ Time Frame: One Day ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be more than 18 years of age
  • Subjects must have a plan to undergo a transcatheter-based structural heart disease procedure that utilize TEE and fluoroscopic guidance

Exclusion Criteria:

  • Subjects with a known contraindication for insertion of the TEE probe (e.g. history of esophageal stricture, scleroderma, etc.), which will be ascertained by a non-invasive imaging specialist (contraindications are routinely assessed in the course of the preoperative workup)Subjects who have a known contraindication for insertion of the TEE probe (e.g. history of esophageal stricture, scleroderma, etc.), which will be ascertained by a non-invasive imaging specialist (contraindications are routinely assessed in the course of the preoperative workup)
  • Pregnant
  • Participating in a competing study
  • Unable or do not provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737969


Locations
Layout table for location information
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Matthew Williams, MD NYU Langone Health

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02737969     History of Changes
Other Study ID Numbers: 16-00048
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by NYU Langone Health:
Transesophageal Echocardiography/angiography (TEE/Angio)
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases