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Left Atrial Appendage Occlusion (LAAC) with Watchman FLX. for Leakiness

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

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.

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

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.
Primary study objectives
LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE.
LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE.
LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE
+1 more
Secondary study objectives
Average depth of implant measured in millimeters (mm)
Average hypo-attenuated thickening (HAT) measured in millimeters (mm)
Average size of device measured in millimeters (mm)
+2 more

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.

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Who is running the clinical trial?

Steven Filby, MDLead Sponsor
Boston Scientific CorporationIndustry Sponsor
730 Previous Clinical Trials
936,869 Total Patients Enrolled
~213 spots leftby Jan 2025