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Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
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)
About the study
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.
What is being tested
- Imaging guidance with TEE and ICE for Left atrial appendage closure (device)
Sponsor: Kansas City Heart Rhythm Research Foundation · Participants: 52 · Started: May 10, 2023
Contact the study team
- Donita Atkins · Phone: 816-651-1969
Official record on ClinicalTrials.gov — NCT06061757
Locations in the U.S.
| Kansas | Kansas City Heart Rhythm Institute - Roe Clinic, Overland Park |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.