Status:
RECRUITING
Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Lead Sponsor:
Kansas City Heart Rhythm Research Foundation
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
Standard intraprocedural guidance for transcatheter left atrial appendage closure (LAAC) employs a multi-modality integrated approach combining fluoroscopy for guiding the delivery system, and transes...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06061757
Start Date
May 10 2023
End Date
December 31 2025
Last Update
August 28 2025
Active Locations (1)
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1
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States, 66211