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Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure

StatusRecruiting
PhaseNot applicable
Started2023-05-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 28, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.

Amendment record

Amended 2 times since 2023-09-25; most recent filed 2025-08-27. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2025-08-27
Amendment Study Status v2
2024-10-14
Amendment Study Status v1
2023-09-25
Original filing
Trial Details
NCT Number NCT06061757
Lead Sponsor Kansas City Heart Rhythm Research Foundation
Conditions Atrial Fibrillation, Stroke
Enrollment 52 participants
Start Date 2023-05-10
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-28