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TEE vs Cardiac CTA for Blood Clot Prevention

N/A
Waitlist Available
Research Sponsored by Steven Filby, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects >18 years old planned to undergo LAAC
eGFR ≥ 30 mL/min per 1.73 m2
Must not have
Subjects below the age of 18
eGFR < 30 mL/min per 1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial involves patients who have undergone a left atrial appendage closure (LAAC) procedure. The standard practice is to have a follow-up ultrasound of the heart (TEE) to monitor the device

Who is the study for?
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.
What is being tested?
The study compares two types of heart imaging: transesophageal echocardiography (TEE), which involves an ultrasound probe in the esophagus, and cardiac CTA, a non-invasive X-ray with contrast dye. Both tests are done on day 90 post-procedure.
What are the potential side effects?
TEE may cause discomfort due to the probe in the esophagus and requires sedation. Cardiac CTA involves exposure to radiation from X-rays and potential allergic reactions or kidney issues related to contrast dye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and scheduled for a left atrial appendage closure.
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My kidney function is at a safe level for the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of adverse events as measured by medical record
Percent of compression as measured by CT scan/TEE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.Experimental Treatment2 Interventions
Patients who are status post LAAC using the Watchman FLX.

Find a Location

Who is running the clinical trial?

Steven Filby, MDLead Sponsor
Boston Scientific CorporationIndustry Sponsor
746 Previous Clinical Trials
857,669 Total Patients Enrolled
14 Trials studying Thrombosis
8,363 Patients Enrolled for Thrombosis
~0 spots leftby Jan 2025
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