Actively Recruiting
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
Led by Baylor Research Institute · Updated on 2026-04-15
444
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.
CONDITIONS
Official Title
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with non-valvular atrial fibrillation (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism with CHADS2 score 652 or CHA2DS2-VASc score 653
- Suitable for oral anticoagulation with warfarin or DOAC and seeking a nonpharmacologic alternative
- Able to undergo pre-procedural imaging with CT or transesophageal echocardiography
- Able to comply with the study protocol
- Provide written informed consent
- Age 18 years or older
You will not qualify if you...
- Presence of intracardiac thrombus on preprocedural TEE or CT
- Previous device implanted for atrial septal defect or patent foramen ovale
- Severe left ventricular dysfunction (LVEF < 40%) or more than moderate valvular heart disease
- Enrollment in another competing or interfering study without approval
- Poor clinical condition like cardiogenic shock preventing function tests
- Planned cardiac intervention between consent and 60 days after procedure
- Any condition posing significant hazard as judged by the investigator
- Pregnant or breastfeeding women or planning pregnancy during the study
- Children under 18 years, prisoners, or those unable to provide consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Baylor Scott and White Heart Hospital
Plano, Texas, United States, 75093
Actively Recruiting
Research Team
B
Bonnie Ostergren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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