TEE/Angio Fusion Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | April 2016 |
| End Date: | August 21, 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Matthew Williams, MD
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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