TEE vs Cardiac CTA for Blood Clot Prevention
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Cardiac CTA and Transesophageal echocardiography (TEE) for blood clot prevention?
Both Cardiac CTA and TEE are effective in detecting blood clots in the heart, with Cardiac CTA being a reasonable alternative to TEE when the goal is to rule out clots in specific heart areas. TEE has been shown to significantly impact the management of patients with stroke or embolism by identifying potential clot sources and guiding treatment decisions.12345
Is Transesophageal Echocardiography (TEE) safe for humans?
How does the treatment TEE differ from other treatments for blood clot prevention?
Transesophageal echocardiography (TEE) is unique because it provides a detailed view of the heart and blood vessels from inside the esophagus, making it superior to other methods like transthoracic echocardiography (TTE) for detecting certain heart abnormalities that can lead to blood clots. It is particularly useful for identifying clots in the left atrium and left atrial appendage, which are critical areas for preventing strokes.156910
What is the purpose of this trial?
The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure.Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.
Research Team
Steven Filby, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Eligibility Criteria
This trial is for patients who have had a procedure to close off a part of the heart called the left atrial appendage. They must be able to undergo both an ultrasound of the heart via the esophagus and a special type of X-ray imaging using contrast dye, scheduled for 90 days after their procedure.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo both TEE and cardiac CTA 90 days after their LAAC procedure
Follow-up
Participants have a routine follow-up visit and a brief phone check-in at 1 year
Treatment Details
Interventions
- Cardiac CTA
- Transesophageal echocardiography (TEE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Steven Filby, MD
Lead Sponsor
University Hospitals Cleveland Medical Center
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology