Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Recruiting · NCT06061757 · Interventional (participants receive a specific treatment) · Lead sponsor: Kansas City Heart Rhythm Research Foundation
View the official record on ClinicalTrials.gov →Interventions studied
Imaging guidance with TEE and ICE for Left atrial appendage closure
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed across 1 US state.
- Kansas City Heart Rhythm Institute - Roe Clinic - Overland Park, Kansas, United States