TEE/Angio Fusion Study

Completed

Interventions: Device: Transesophageal Echocardiography/angiography (TEE/Angio)

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TEE/Angio fusion software	Transesophageal Echocardiography/angiography (TEE/Angio)	Patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes TEE and fluoroscopic guidance

Primary Outcome Measures

Name	Time	Method
Procedural Time'	One day
Fluoroscopy Time	One Day
Total Radiation Dose	One Day
Dose Area Product of Radiation Exposure	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	One day

Secondary Outcome Measures

Name	Time	Method

Locations (1): New York University Langone Medical Center
🇺🇸
New York, New York, United States

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial