Actively Recruiting
Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2025-08-28
52
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 to 80 years
- History of atrial fibrillation or atrial flutter
- Scheduled for endocardial left atrial appendage closure using Amplatzer Amulet or WATCHMAN FLX device
You will not qualify if you...
- Unable or unwilling to provide written informed consent
- Not planning to follow up with the study practice after the procedure
- Complex anatomy preventing endocardial left atrial appendage closure
- Presence of a thrombus in the left atrial appendage
- Pericardial effusion detected on pre-operative TEE or CCTA
- Currently pregnant (confirmed by serum beta HCG test)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States, 66211
Actively Recruiting
Research Team
D
Donita Atkins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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