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Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure

RecruitingNAAges 18 Years - 80 YearsAllKansas City Heart Rhythm Research Foundation
NCT06061757 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male/Females * Age:18-80 years * History of Atrial Fibrillation/Atrial flutter * Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device Exclusion Criteria: * Inability or unwillingness of an individual to give written informed consent * Patient not following with our practice after the procedure * Complex anatomy for endocardial LAAC * Thrombus in LAA * Patients with pericardial effusion in pre-op TEE/CCTA * Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)
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What it tests

  • Imaging guidance with TEE and ICE for Left atrial appendage closure
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Where

1 site
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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