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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

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

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
737 Previous Clinical Trials
853,916 Total Patients Enrolled
~213 spots leftby Jan 2025
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