TEE/Angio Fusion Study
Use of Transesophageal Echocardiography/Angiography Fusion Software Prototype for Structural Heart Disease Procedures
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2018
CompletedJanuary 6, 2020
January 1, 2020
2.1 years
March 24, 2016
January 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
TEE/Angio fusion software
Patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes TEE and fluoroscopic guidance
Interventions
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.
Eligibility Criteria
Patients planned to undergo a transcatheter-based structural heart disease procedure that utilizes TEE and fluoroscopic guidance at the NYU Langone Medical Center
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University Langone Medical Center
New York, New York, 10016, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Williams, MD
NYU Langone Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2016
First Posted
April 14, 2016
Study Start
April 1, 2016
Primary Completion
May 2, 2018
Study Completion
May 2, 2018
Last Updated
January 6, 2020
Record last verified: 2020-01