Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this 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.
Sponsor: Kansas City Heart Rhythm Research Foundation
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
Overland Park
Source: ClinicalTrials.gov · NCT06061757 · last updated 2025-08-28