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Study of 4D-ICE for Left Atrial Appendage Closure

This study is looking at whether a new imaging tool called 4D Intracardiac Echocardiography (4D-ICE) can guide Left Atrial Appendage Closure (LAAC) procedures as well as the current standard, Transesophageal Echocardiography (TEE). LAAC is a procedure for people with Atrial Fibrillation (an irregular heartbeat) to help prevent strokes. The study will enroll about 52 participants, aged 18 to 80, who have Atrial Fibrillation and are scheduled to receive an Amplatzer Amulet or WATCHMAN FLX device for LAAC. The main goal is to see if the LAAC device is successfully implanted one day after the procedure. This research aims to find a way to perform these procedures without general anesthesia, which TEE usually requires.

Study design
This is a single-center study with two groups, involving about 52 participants. It is not randomized.
What's involved
Participants will undergo the LAAC procedure with imaging guidance. They will be followed for 12 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06061757

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

Recruiting
NAAges 18–80InterventionalSupportive care
Kansas City Heart Rhythm Research Foundation
~52 participants
Updated 2025-08-28 on ClinicalTrials.gov
What's tested:Imaging guidance with TEE and ICE for Left atrial appendage closure

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Success of Implantation of Left Atrial Appendage Closure (LAAC) device
Measured over 1 Day

Conditions

Atrial Fibrillation
Stroke

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NCT06061757

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Dhanunjaya Lakkireddy, MD · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute

Who to contact

Donita Atkins
[email protected]
816-651-1969
Email the study team

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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)

What this trial measures

  • Success of Implantation of Left Atrial Appendage Closure (LAAC) device1 Day

    Success of Implantation of Amulet or Watchman FLX device