TEE/Angio Fusion Study

Use of Transesophageal Echocardiography/Angiography Fusion Software Prototype for Structural Heart Disease Procedures

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.

Study Overview

• Status: Completed
• Conditions: Structural Heart Disease
• Intervention / Treatment: Device: Transesophageal Echocardiography/angiography (TEE/Angio)

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes TEE and fluoroscopic guidance at the NYU Langone Medical Center

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

TEE/Angio fusion software; Patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes TEE and fluoroscopic guidance

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Time'		One day
Dose Area Product of Radiation Exposure	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%).	One day
Degree of residual valvular or paravalvular regurgitation		One day
Total Radiation Dose		One Day
Fluoroscopy Time		One Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Matthew Williams, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Transesophageal Echocardiography/angiography (TEE/Angio)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 16-00048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No