TEE/Angio Fusion Study
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|ClinicalTrials.gov Identifier: NCT02737969|
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2016
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Structural Heart Disease||Device: Transesophageal Echocardiography/angiography (TEE/Angio)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- Procedural Time` [ Time Frame: One day ]
- 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%).
- Degree of residual valvular or paravalvular regurgitation [ Time Frame: One day ]
- Total Radiation Dose [ Time Frame: One Day ]
- Fluoroscopy Time [ Time Frame: One Day ]
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
|United States, New York|
|New York University Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Matthew Williams, MD||NYU Langone Health|