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)
Kansas City Heart Rhythm Research Foundation
52 participants
May 10, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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)
Interventions
The occluder size for both LAAC devices will be selected based on the maximal diameter of the LAA orifice following the manufacturer guidelines and using the maximal length of the LAA measured on Echocardiogram. Intraprocedural measurements of the LAA width and depth were acquired on both ICE and TEE per protocol. Both ICE and TEE will be used to assess for any procedural complications prior to insertion of the device delivery sheath.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06061757